Trial Outcomes & Findings for A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia (NCT NCT01486784)

Last Updated: 2021-06-24

Results Overview

Safety of birinapant will be measured as the number of adverse events per dosing level occurring with greater than 5% frequency in the total evaluable subject population. Adverse events are any untoward medical occurrences experienced by research study participants. These events are documented and assessed for severity and relation to the study drug by the treating investigator, using the Common Terminology for Criteria for Adverse Events for severity, and information on known side effects of the study drug for relation.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

27 participants

Primary outcome timeframe

First day of study treatment to 30 days after last study treatment. The average length of time for adverse event monitoring was 14 weeks.

Results posted on

2021-06-24

Participant Flow

Of the 27 subjects enrolled, only 17 completed Cycle 1 of study treatment, and are therefore considered evaluable. 5 subjects withdrew or were taken off study prior to receiving study drug, 1 came off study due to disease progression, 3 were removed from the study, and 1 chose to withdraw prior to completing Cycle 1.

Participant milestones

Participant milestones
Measure	Phase 1 DL1 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1a 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1b 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Overall Study STARTED	3	7	6	1	5	5
Overall Study Completed Cycle 1	2	6	3	1	3	2
Overall Study Received Treatment	3	7	5	1	3	2
Overall Study COMPLETED	3	7	5	1	3	2
Overall Study NOT COMPLETED	0	0	1	0	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 DL-1a 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Overall Study Withdrawal by Subject	1	1	2
Overall Study Subject did not meet entry criteria	0	1	0
Overall Study Death	0	0	1

Baseline Characteristics

A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 DL1 n=3 Participants 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1 n=7 Participants 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1a n=6 Participants 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1b n=1 Participants 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c n=5 Participants 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d n=5 Participants 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	6 Participants n=115 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	21 Participants n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	14 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	13 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	25 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	00 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants	22 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants
Region of Enrollment United States	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	27 Participants n=115 Participants

PRIMARY outcome

Timeframe: First day of study treatment to 30 days after last study treatment. The average length of time for adverse event monitoring was 14 weeks.

Outcome measures

Outcome measures
Measure	Phase 1 DL1 n=3 Participants 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1 n=7 Participants 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1a n=5 Participants 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1b n=1 Participants 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c n=3 Participants 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d n=2 Participants 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
The Safety of Birinapant (TL32711) in Subjects With Acute Myeloid Leukemia, Myelodysplastic Syndromes and Acute Lymphoblastic Leukemia. Acute Lymphocytic Leukemia.	25 Adverse Events	34 Adverse Events	35 Adverse Events	10 Adverse Events	3 Adverse Events	2 Adverse Events

PRIMARY outcome

Timeframe: First day of study treatment to 30 days after last study treatment. The average length of time for adverse event monitoring was 14 weeks.

This outcome measure will be defined as the number of dose limiting toxicities per dosing level. Dose limiting toxicities are pre-defined medical events that may be related to the dosing of the study drug. These toxicities are documented and assessed for severity based on pre-defined thresholds, and may result in modification of the study drug dosing.

Outcome measures

Outcome measures
Measure	Phase 1 DL1 n=3 Participants 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1 n=7 Participants 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1a n=5 Participants 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1b n=1 Participants 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c n=4 Participants 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d n=2 Participants 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Number of Dose Limiting Toxicities Per Dosing Level.	2 Dose Limiting toxicities	0 Dose Limiting toxicities	0 Dose Limiting toxicities	0 Dose Limiting toxicities	1 Dose Limiting toxicities	0 Dose Limiting toxicities

Adverse Events

Phase 1 DL1

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Phase 1 DL-1

Serious events: 6 serious events

Other events: 7 other events

Deaths: 4 deaths

Phase 1 DL-1a

Serious events: 5 serious events

Other events: 5 other events

Deaths: 5 deaths

Phase 1 DL-1b

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 1 DL-1c

Serious events: 4 serious events

Other events: 4 other events

Deaths: 4 deaths

Phase 1 DL-1d

Serious events: 3 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 DL1 n=3 participants at risk 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1 n=7 participants at risk 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1a n=6 participants at risk 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1b n=1 participants at risk 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c n=5 participants at risk 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d n=5 participants at risk 22mg/m2/dose IV twice per week x 4weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Nervous system disorders Headache	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Blood and lymphatic system disorders Febrile neutropenia	100.0% 3/3 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	57.1% 4/7 • Number of events 4 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 4 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Lipase increased	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Skin infection	33.3% 1/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Airway Obstruction	33.3% 1/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Serum amylase increase	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Sepsis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Fever	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Fatigue	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Increase creatinine	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Facial nerve disorder	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Peripheral motor neurpathy	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Decrease neutrophil count	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Platelet count decreased	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Infection, bladder	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Catheter related infection	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Death NOS	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	42.9% 3/7 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	50.0% 3/6 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Sudden death NOS	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Intracranial hemorrhage	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Cardiac disorders Cardiac arrest	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Dyspena	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.

Other adverse events

Other adverse events
Measure	Phase 1 DL1 n=3 participants at risk 26mg/m2/dose IV once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1 n=7 participants at risk 17mg/m2 IV/dose once per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1a n=6 participants at risk 17mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1b n=1 participants at risk 17mg/m2/dose IV three times per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1c n=5 participants at risk 22mg/m2/dose IV twice per week x 3 weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion	Phase 1 DL-1d n=5 participants at risk 22mg/m2/dose IV twice per week x 4weeks of 4 week cycle Birinapant: IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
Metabolism and nutrition disorders Hypokalemia	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	57.1% 4/7 • Number of events 5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Skin Disorders Other- Eczema	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Serum amylase increased	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	42.9% 3/7 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Lipase increased	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	57.1% 4/7 • Number of events 4 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Thrombocytopenia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 7/7 • Number of events 7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	83.3% 5/6 • Number of events 5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	60.0% 3/5 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Sweating	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Eye disorders Transient Unilateral Blindness	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	42.9% 3/7 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Chills	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	85.7% 6/7 • Number of events 6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	83.3% 5/6 • Number of events 5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	60.0% 3/5 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Neutropenia	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 7/7 • Number of events 7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	83.3% 5/6 • Number of events 5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Eye disorders Flashing lights	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Skin Infection	33.3% 1/3 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Fever	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Headache	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	42.9% 3/7 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	60.0% 3/5 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Leukopenia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	42.9% 3/7 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	50.0% 3/6 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Cardiac disorders Sinus Tachycardia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, jaw sensitivity	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Pneumonia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Psychiatric disorders Depression	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 4 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Dysesthesia	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Cardiac disorders Atrial flutter	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Cardiac disorders Cardio Myopathy	33.3% 1/3 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Hypophosphatemia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Stomach pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Eye disorders Floaters	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Eye disorders Eye disorder	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Edema	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Psychiatric disorders Anxiety	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Eye disorders Watering Eyes	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Creatinine Increased	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Eye disorders Scleral Hemorrhage	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Mouth sores	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Mouth Pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Bloating	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Leg Pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	33.3% 2/6 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	28.6% 2/7 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations Blood Bilirubin Increased	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	14.3% 1/7 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Constipation	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	50.0% 3/6 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Skin Subcutaneous Disorders, Other	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Infection, Other	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Hyperhydrosis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Gum Infection	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Dry Mouth	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Renal and urinary disorders Renal and Urinary Disorders, Other	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Renal and urinary disorders Urinary urgency	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Pain, left trunk	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Pain, right trunk	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Skin Infection	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	16.7% 1/6 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Immune system disorders Autoimmue disorder	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	100.0% 1/1 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Psychiatric disorders Insomnia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	40.0% 2/5 • Number of events 2 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Investigations White Blood Cell Decreased	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Mucositis Oral	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Musculoskeletal and connective tissue disorders Pain, back	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
General disorders Local Facial Edema	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Nervous system disorders Facial muscle weakness	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Infections and infestations Pharyngitis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Gastrointestinal disorders Gingivitis	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/3 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/7 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/6 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	20.0% 1/5 • Number of events 1 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.	0.00% 0/5 • Adverse events will be captured for each subject from the period from their initiation of study treatment to 30 days following their last administration of study treatment. The average length of time for adverse event monitoring was 14 weeks. Some adverse events were reported, assessed, and monitored per the CTCAE terminology using the Organ Class System rather than the specific event description. Ongoing adverse events have been captured as a single incidence to reflect the most severe grade of each event.

Additional Information

Dr. Noelle Frey

Abramson Cancer Center at the University of Pennsylvania

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place