Trial Outcomes & Findings for Evaluating the Efficacy of Atezolizumab in Advanced Non-small Cell Lung Cancer (NSCLC) (NCT NCT03014648)

NCT ID: NCT03014648

Last Updated: 2023-12-13

Results Overview

Best response recorded is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per RECIST v1.1: Complete Response (CR) - Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: Approximately 53.5 months
• Results posted on: 2023-12-13

Participant Flow

Participant milestones

Measure	Atezolizumab Atezolizumab was administered through an IV over 60 minutes at a dose of 1200mg on Day 1 of each 21-day cycle. If the first dose was tolerated without any infusion-related adverse events, the following doses were administered over 30 minutes.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Efficacy of Atezolizumab in Advanced Non-small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	Total n=28 Participants Total of all reporting groups
Age, Continuous	73.50 years STANDARD_DEVIATION 6.65 • n=93 Participants	65.67 years STANDARD_DEVIATION 13.65 • n=4 Participants	66.41 years STANDARD_DEVIATION 10.59 • n=27 Participants	68.5 years STANDARD_DEVIATION 10.3 • n=483 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	15 Participants n=483 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	0 Participants n=4 Participants	10 Participants n=27 Participants	13 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	3 Participants n=4 Participants	15 Participants n=27 Participants	26 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) White	8 Participants n=93 Participants	1 Participants n=4 Participants	15 Participants n=27 Participants	24 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Histology ADENOCARCINOMA IN SITU, NOS	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Histology ADENOCARCINOMA, METASTATIC, NOS	2 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Histology ADENOCARCINOMA, N/A	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Histology ADENOCARCINOMA, NOS	4 Participants n=93 Participants	3 Participants n=4 Participants	10 Participants n=27 Participants	17 Participants n=483 Participants
Histology LARGE CELL CARCINOMA, METASTATIC	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Histology NON-SMALL CELL CA	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Histology SQUAMOUS CELL CA METASTATIC, NOS	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Histology SQUAMOUS CELL CARCINOMA, NOS	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants

PRIMARY outcome

Timeframe: Approximately 53.5 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and had at least one scan for evaluation of radiologic response.

Best response recorded is recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per RECIST v1.1: Complete Response (CR) - Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	CR/PR Cohort n=7 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=16 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Best Overall Response (BOR) Progressive Disease	2 Participants	2 Participants	9 Participants
Best Overall Response (BOR) Stable Disease	4 Participants	1 Participants	5 Participants
Best Overall Response (BOR) Partial Response	1 Participants	0 Participants	1 Participants
Best Overall Response (BOR) Unknown	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Approximately 56.5 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and evaluated for radiologic response.

The length of time that a tumor continues to respond to treatment from first documentation of response until disease progression.Per RECISIt v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	CR/PR Cohort n=1 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=1 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Duration of Response (DOR)	6 months	0 months	—

SECONDARY outcome

Timeframe: Approximately 56.5 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and evaluated for radiologic response.

The length of time during and after treatment that a patient lives with disease but without disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Progression-free Survival (PFS)	4.00 months Interval 2.0 to 9.0	2.00 months Interval 1.0 to Upper bound not reached	2.00 months Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and evaluated for radiologic response.

The number of patients alive without disease progression at 6 months, per RECIST v1.1. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
6-month Progression-free Survival (PFS)	3 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and evaluated for radiologic response.

The number of patients alive without disease progression at 12 months, per RECIST v1.1. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
12-month Progression-free Survival (PFS)	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy and evaluated for radiologic response.

The number of patients alive without disease progression at 24 months, per RECIST v1.1. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
24-month Progression-free Survival (PFS)	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Approximately 56.5 months

Population: All patients participating in the study.

The length of time from start of treatment that patients remain still alive.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Overall Survival (OS)	7.00 months Interval 2.0 to Upper 95% CI not reached	11.00 months Interval 3.0 to Upper 95% CI not reached	6.00 months Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: Up to 6 months

Population: All study participants.

The number of participants alive at 6 months.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
6-month Overall Survival (OS)	4 Participants	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: All study participants.

The number of patients alive at 12 months.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
12-month Overall Survival (OS)	3 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: All study participants.

The number of patients alive at 24 months.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
24-month Overall Survival (OS)	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Approximately 56.5 months

Population: Patients treated with atezolizumab who were previously treated with anti-PD-1 therapy.

Number of patients that experienced grade 3 or greater Adverse events per the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 4, determined to be at least possibly, probably or definitely related to treatment, or that result in dose holds or reductions, will be collected and reported. Grade 3 = Severe AE and Grade 4 = Life-threatening or disabling AE. Adverse events and serious adverse events will be tabulated in order of prevalence, with the highest grade reported by each patient.

Outcome measures

Measure	CR/PR Cohort n=8 Participants Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 Participants Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 Participants Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Adverse Events ≥ Grade 3 Fatigue	1 Participants	0 Participants	0 Participants
Adverse Events ≥ Grade 3 Infusion related reaction	1 Participants	0 Participants	0 Participants
Adverse Events ≥ Grade 3 Diarrhea	1 Participants	0 Participants	0 Participants
Adverse Events ≥ Grade 3 Lipase increased	0 Participants	0 Participants	1 Participants
Adverse Events ≥ Grade 3 Serum amylase increased	0 Participants	0 Participants	1 Participants
Adverse Events ≥ Grade 3 Generalized muscle weakness	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 years

PD-L1 protein expression will be measured as positive (present) or negative (absent) in tissue from a biopsy conducted after discontinuation of the prior therapy and before initiation of study drug.

Outcome measures

Outcome data not reported

Adverse Events

CR/PR Cohort

Serious events: 3 serious events

Other events: 8 other events

Deaths: 8 deaths

SD Cohort

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

PD Cohort

Serious events: 13 serious events

Other events: 17 other events

Deaths: 17 deaths

Serious adverse events

Measure	CR/PR Cohort n=8 participants at risk Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 participants at risk Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 participants at risk Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Blood and lymphatic system disorders Anemia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Cardiac disorders Asystole	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Cardiac disorders Atrial fibrillation	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Endocrine disorders Hypothyroidism	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Colonic perforation	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Nausea	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Vomiting	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Fever	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders General disorders and administration site conditions - Other, specifyfailure to thrive	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Infusion related reaction	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Pain	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Hepatobiliary disorders Specifycholelithiasis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Abdominal infection	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Lung infection	37.5% 3/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Sepsis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Sinusitis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Alanine aminotransferase increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Alkaline phosphatase increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Anorexia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Dehydration	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hyponatremia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyRLE/R lower back pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Nervous system disorders Headache	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Nervous system disorders Paresthesia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Nervous system disorders Stroke	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Psychiatric disorders Confusion	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2

Other adverse events

Measure	CR/PR Cohort n=8 participants at risk Patients with Complete Response (CR) or Partial Response (PR) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	SD Cohort n=3 participants at risk Patients with Stable Disease (SD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min	PD Cohort n=17 participants at risk Patients with Progressive Disease (PD) Atezolizumab was given on Day 1 of a 21-day cycle at 1200 mg IV over 60 (plus or minus 15) minutes for first infusion, or decreased to 30 +/-10 min
Investigations Creatinine increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations White blood cell decreased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Upper respiratory infection	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Urinary tract infection	37.5% 3/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Injury, poisoning and procedural complications Fracture	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Injury, poisoning and procedural complications Fall	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Injury, poisoning and procedural complications Spinal fracture	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Alanine aminotransferase increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations INR increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Investigations - Other, specifyLDh increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Investigations - Other, specifyPT increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Platelet count decreased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Blood bilirubin increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Cardiac troponin T increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Hemoglobin increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Investigations - Other, specifythyroid stimulating hormone increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Sore throat	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Lipase increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Alkaline phosphatase increased	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Investigations - Other, specifyLDH increased	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Serum amylase increased	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Weight loss	37.5% 3/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Lymphocyte count decreased	50.0% 4/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Investigations Activated partial thromboplastin time prolonged	50.0% 4/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hypomagnesemia	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hypercalcemia	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Metabolism and nutrition disorders Anorexia	50.0% 4/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyBiopsy site pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyDJD - spine	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyL scapular pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specifyLL rib pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Nervous system disorders Dizziness	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Nervous system disorders Headache	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Nervous system disorders Paresthesia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Psychiatric disorders Confusion	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Psychiatric disorders Insomnia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Psychiatric disorders Agitation	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Psychiatric disorders Anxiety	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Renal and urinary disorders - Other, specifyhesitancy	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Renal and urinary disorders - Other, specifymoderate bacteria in UA	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Urinary incontinence	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Urinary urgency	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Urine discoloration	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Hematuria	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Renal and urinary disorders Proteinuria	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Reproductive system and breast disorders Pelvic pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Reproductive system and breast disorders Scrotal pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifydecreased breath sounds	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyhemoptysis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyhemoptysis (intermittent)	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyupper respiratory infection	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Pneumonitis	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Postnasal drip	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifyCOVID-19	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specifynonproductive cough	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Nasal congestion	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Productive cough	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Wheezing	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Respiratory, thoracic and mediastinal disorders Cough	37.5% 3/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyBump in neck	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyL armpit lump	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyR lower breast	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyright forearm wound	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyskin tear on left arm	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specifyPruritus chest	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Vascular disorders Flushing	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Vascular disorders Hematoma	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Vascular disorders Hypertension	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Vascular disorders Hypotension	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Blood and lymphatic system disorders Lymph node pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Blood and lymphatic system disorders Leukocytosis	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Blood and lymphatic system disorders Anemia	75.0% 6/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	64.7% 11/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Cardiac disorders Atrial fibrillation	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Cardiac disorders Cardiac disorders - Other, specifyVolume overload	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Cardiac disorders Sinus bradycardia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Cardiac disorders Sinus tachycardia	50.0% 4/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Ear and labyrinth disorders Ear pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Endocrine disorders Endocrine disorders - Other, specifyTSH increase	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Endocrine disorders Endocrine disorders - Other, specifyTSH increased	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Endocrine disorders Endocrine disorders - Other, specifyelevated TSH	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Endocrine disorders Hypothyroidism	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Eye disorders Dry eye	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Eye disorders Glaucoma	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Eye disorders Blurred vision	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Esophagitis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Gastritis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyhiatal hernia	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Gastrointestinal disorders - Other, specifyloose stools	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Toothache	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Vomiting	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	23.5% 4/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Abdominal distension	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Ascites	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Dry mouth	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Abdominal pain	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	17.6% 3/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Diarrhea	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	29.4% 5/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Nausea	25.0% 2/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	47.1% 8/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Gastrointestinal disorders Constipation	37.5% 3/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	29.4% 5/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Fever	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Localized edema	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Malaise	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Neck edema	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Non-cardiac chest pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Pain	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Infusion related reaction	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Chills	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Edema limbs	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders General disorders and administration site conditions - Other, specifypain, leg	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Flu like symptoms	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	11.8% 2/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
General disorders Fatigue	50.0% 4/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	33.3% 1/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	52.9% 9/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Hepatobiliary disorders Cholecystitis	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Hepatobiliary disorders Hepatobiliary disorders - Other, specifyLDH increased	12.5% 1/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2
Infections and infestations Breast infection	0.00% 0/8 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	0.00% 0/3 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2	5.9% 1/17 • Approximately 56.5 months CTCAE (4.0) Serious Adverse Events (SAE) are events ≥ Grade 3 Other Adverse Events (AE) are events ≤ Grade 2

Additional Information

Barbara M Stadterman, Regulatory Supervisor, Clinical Research Services

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place