Trial Outcomes & Findings for Phase I Study of APX005M in Pediatric Central Nervous System Tumors (NCT NCT03389802)

Last Updated: 2025-09-29

Results Overview

DLTs were defined as adverse events (AE) at least possibly attributed to APX005M that occurred during the first 2 courses (6 weeks) following APX005M administration. DLTs included any APX005M-related AE that led to dose reduction or permanent cessation of therapy or resulted in a treatment delay \>2 weeks. Hematologic DLTs included grade 3 neutropenia with fever, any grade 4 hematologic toxicity except lymphopenia, and grade 3 thrombocytopenia on 2 separate days or requiring platelet transfusion on 2 days within a 7-day period. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, grade 3 or higher cytokine release syndrome, or any grade 3 non-hematologic toxicity with some exceptions such as grade 3 nausea/vomiting \<5 days or grade 3 diarrhea that responded to treatment within 5 days.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-09-29

Participant Flow

Patients ≥1 and ≤21 years of age with recurrent or refractory primary malignant central nervous system (CNS) tumors (Stratum 1) or newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum 2) were enrolled at Pediatric Brain Tumor Consortium (PBTC) member institutions. The first patient was enrolled on 3/1/2018 and the last patient was enrolled on 1/20/2023. Accrual was closed after the maximum tolerated dose/recommended phase II dose was determined for both strata.

Patients with recurrent or refractory primary malignant CNS tumors were enrolled on stratum 1, and patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were enrolled on stratum 2. A total of 32 patients were enrolled (31 eligible). Twenty-one (21) stratum 1 patients were enrolled; 1 of these patients was deemed to be ineligible as an eligibility assessment was not performed. Eleven (11) stratum 2 patients were enrolled (all deemed eligible).

Participant milestones

Participant milestones
Measure	Stratum 1, Dose Level 1 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 2 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Overall Study STARTED	3	3	15	6	5
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	15	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Stratum 1, Dose Level 1 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 2 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Overall Study Lack of Efficacy	3	3	13	6	1
Overall Study Adverse Event	0	0	1	0	4
Overall Study Subject deemed ineligible after enrollment	0	0	1	0	0

Baseline Characteristics

Phase I Study of APX005M in Pediatric Central Nervous System Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stratum 1, Dose Level 1 n=3 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 2 n=3 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 n=14 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 n=6 Participants Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 n=5 Participants Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Total n=31 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	4.2 Year n=5 Participants	13.2 Year n=7 Participants	9.7 Year n=5 Participants	6.6 Year n=4 Participants	8.8 Year n=21 Participants	8.9 Year n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	18 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	13 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	17 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	19 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Patients who were evaluable for DLT assessment were included in this analysis. Of 31 eligible patients enrolled, 2 patients were not evaluable for DLT assessment due to early disease progression (received less than 2 doses of therapy).

Outcome measures

Outcome measures
Measure	Stratum 1 n=3 Participants Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.	Stratum 1, Dose Level 2 n=3 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 n=12 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 n=6 Participants Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 n=5 Participants Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Number of Patients Who Experienced Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: 6 weeks (first 2 courses of treatment)

Population: Patients who were enrolled on Stratum 1 and evaluable for dose-finding assessment were used to determine the MTD for Stratum 1. Of 20 eligible patients enrolled on Stratum 1, 2 were not evaluable for dose-finding assessment due to early progressive disease (these 2 participants received less than 2 doses of treatment). The remaining 18 patients were used to determine the MTD/RP2D for Stratum 1.

Based on the 3+3 design, the MTD of APX005M was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT, and the next higher dose level was determined to be too toxic. A total of 12 subjects were to be treated at the MTD/RP2D to further define the toxicity profile. Stratum 1 consisted of patients with recurrent or refractory primary malignant central nervous system tumors.

Outcome measures

Outcome measures
Measure	Stratum 1 n=18 Participants Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.	Stratum 1, Dose Level 2 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 1	0.6 mg/kg	—	—	—	—

PRIMARY outcome

Timeframe: 6 weeks (first 2 courses of treatment)

Population: Patients who were enrolled on Stratum 2 and were evaluable for dose-finding assessment were used to determine the MTD for Stratum 2. Of 11 patients enrolled on Stratum 2, all were evaluable for dose-finding assessment and used to determine the MTD for Stratum 2.

The starting dose level for Stratum 2 was one dose level below the RP2D determined in Stratum 1. If there were no dose-limiting toxicities in the first 3 patients enrolled on Stratum 2, then we escalated to the Stratum 1 RP2D and could treat 6 diffuse intrinsic pontine glioma (DIPG) patients simultaneously. The RP2D was defined as the dose level at which 6 patients were treated with no more than one dose-limiting toxicity. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).

Outcome measures

Outcome measures
Measure	Stratum 1 n=11 Participants Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.	Stratum 1, Dose Level 2 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) of APX005M in Stratum 2	0.3 mg/kg	—	—	—	—

PRIMARY outcome

Timeframe: 12 weeks

Serial blood samples for APX005M pharmacokinetic studies were collected during courses 1 and 2 at pre-dose, at the end of infusion, and at 4, 24 ± 1 (Day 2), and 168 ± 4 hours (Day 8) from the start of infusion in that course and during courses 3 and 4 at pre-dose and end of induction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Newly diagnosed DIPG patients who were enrolled on Stratum 2 and received at least one dose of APX005M were included in this analysis.

Overall survival was defined as the time interval from treatment initiation to death from any cause or to date of last follow-up for survivors. Survival was estimated using the method of Kaplan and Meier. The 1-year estimate of survival is reported with a 95% confidence interval; estimates are reported by dose level. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).

Outcome measures

Outcome measures
Measure	Stratum 1 n=6 Participants Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.	Stratum 1, Dose Level 2 n=5 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Overall Survival for Stratum 2 (DIPG) Patients	40.0 Percent probability Interval 4.9 to 75.1	25.0 Percent probability Interval 0.0 to 55.0	—	—	—

SECONDARY outcome

Timeframe: 1 year

Population: Newly diagnosed DIPG patients who were enrolled on Stratum 2 and received at least one dose of APX005M are included in this analysis.

Progression-free survival (PFS) was defined as the time interval from treatment initiation to date of first event (relapsed or progressive disease based on imaging or clinical progression or death from any cause) or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. The 1-year estimate of PFS is reported with a 95% confidence interval. PFS estimates were reported separately by dose level. Stratum 2 patients were those with newly diagnosed diffuse intrinsic pontine glioma (DIPG).

Outcome measures

Outcome measures
Measure	Stratum 1 n=6 Participants Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.	Stratum 1, Dose Level 2 n=5 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Progression-free Survival for Stratum 2 (DIPG) Patients	16.7 Percent probability Interval 0.0 to 37.9	26.7 Percent probability Interval 0.0 to 58.3	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Stratum 2 patients with measurable disease present at baseline who received at least one dose of therapy and had their disease re-evaluated were considered evaluable for objective response. Two participants were considered not evaluable as they did not have their disease re-evaluated.

Complete or partial responses were considered responses. Response was evaluated by imaging or clinical progression. The response rate (percentage of participants with responses) is reported with a 95% Blyth-Still-Casella confidence interval. Response rates are reported separately by dose level.

Outcome measures

Outcome measures
Measure	Stratum 1 n=6 Participants Recurrent, progressive, or refractory primary malignant non-brainstem CNS tumor patients treated with APX005M. The dose levels studied were 0.1 mg/kg (dose level 1), 0.3 mg/kg (dose level 2), and 0.6 mg/kg (dose level 3). APX005M was administered at the assigned dose level every 21 days (3 weeks). Patients could receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death.	Stratum 1, Dose Level 2 n=3 Participants Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Overall Response Rate for Stratum 2 (DIPG) Patients	0 percentage Interval 0.0 to 40.2	0 percentage Interval 0.0 to 63.2	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Of the 11 Stratum 2 patients (6 dose level 2, 5 dose level 3), 2 (both in dose level 3) were considered not evaluable for response. As no participants had complete or partial responses, it was not possible to calculate duration of response.

Complete or partial responses were considered responses. Response was evaluated by imaging or clinical progression. Duration of response was measured from the time measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease was objectively documented.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-treatment and up to 9 weeks post-treatment

Concentration of the cytokine Tumor Necrosis Factor-alpha (TNF-alpha) (in pg/ml)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-treatment and up to 9 weeks post-treatment

Concentration of the cytokine Interleukin-8 (IL-8) (in pg/ml)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-treatment and up to 9 weeks post-treatment

Characterization of T cell phenotypes in human PBMC

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 of treatment

Mutational burden as detected by comparing whole exome sequencing of tumor tissue and PBMC

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 of treatment

Mutation burden as detected by comparing the RNA sequencing of tumor tissue and PBMC

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0 of treatment

Mutational burden as detected by comparing the TCR sequencing of tumor tissue and/or PBMC. For Stratum 2 (DIPG) patients without tumor samples, TCRseq analysis will be performed, which only requires PBMCs.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Approximately 2 years

Serial blood samples for anti-drug-antibodies (ADA) are to be collected prior to dosing on courses 1 through 4, then every third course (courses 7 and 10), and then every 4 courses (courses 14, 18, 22, 26, 30, 34) until the end of therapy visit and collected into serum tubes.

Outcome measures

Outcome data not reported

Adverse Events

Stratum 1, Dose Level 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Stratum 1, Dose Level 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Stratum 1, Dose Level 3

Serious events: 4 serious events

Other events: 14 other events

Deaths: 5 deaths

Stratum 2, Dose Level 2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 4 deaths

Stratum 2, Dose Level 3

Serious events: 5 serious events

Other events: 5 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Stratum 1, Dose Level 1 n=3 participants at risk Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 2 n=3 participants at risk Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 n=14 participants at risk Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 n=6 participants at risk Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 n=5 participants at risk Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Investigations Neutrophil count decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Platelet count decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Nausea	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	14.3% 2/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Fatigue	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Fever	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Hepatobiliary disorders Hepatic failure	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Immune system disorders Allergic reaction	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	40.0% 2/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Infections and infestations Sepsis	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Infections and infestations Upper respiratory infection	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	21.4% 3/14 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Blood bilirubin increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Dysarthria	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Edema cerebral	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Encephalopathy	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Headache	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Muscle weakness right-sided	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Seizure	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Somnolence	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Psychiatric disorders Anxiety	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Psychiatric disorders Confusion	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.

Other adverse events

Other adverse events
Measure	Stratum 1, Dose Level 1 n=3 participants at risk Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 2 n=3 participants at risk Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 1, Dose Level 3 n=14 participants at risk Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 2 n=6 participants at risk Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.	Stratum 2, Dose Level 3 n=5 participants at risk Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
Investigations Lymphocyte count decreased	66.7% 2/3 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	66.7% 2/3 • Number of events 6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 7/14 • Number of events 18 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	80.0% 4/5 • Number of events 9 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Chills	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Vascular disorders Flushing	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations White blood cell decreased	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	100.0% 3/3 • Number of events 7 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	64.3% 9/14 • Number of events 22 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 3/6 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	60.0% 3/5 • Number of events 7 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 7/14 • Number of events 15 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 3/6 • Number of events 6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	40.0% 2/5 • Number of events 9 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	66.7% 2/3 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	35.7% 5/14 • Number of events 12 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	40.0% 2/5 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	66.7% 2/3 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	85.7% 12/14 • Number of events 20 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	83.3% 5/6 • Number of events 6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	100.0% 5/5 • Number of events 14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Eye disorders Periorbital edema	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Fibrinogen decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Dizziness	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Psychiatric disorders Insomnia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Vascular disorders Hypotension	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Vascular disorders Hypertension	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	60.0% 3/5 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Constipation	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Dysarthria	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Nystagmus	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Somnolence	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Blood bicarbonate decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Eye disorders DOUBLE VISION	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Malaise	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations CD4 lymphocytes decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations PANCYTOPENIA	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations RBC DECREASED	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations TOTAL PROTEIN DECREASED	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Muscle weakness left-sided	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Muscle weakness right-sided	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Seizure	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders ERYTHEMATOUS RASH TO TRUNK, CHEEKS, EARS	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders ERYTHEMATUS PRURITIC RASH	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders HIVES	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders HYPERSENSITIFITY & HYPERESETHESIA	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Stomach pain	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Headache	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Alkaline phosphatase increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Nervous system disorders Abducens nerve disorder	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	14.3% 2/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	14.3% 2/14 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	14.3% 2/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	21.4% 3/14 • Number of events 5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Blood bilirubin increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	21.4% 3/14 • Number of events 5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	60.0% 3/5 • Number of events 6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	21.4% 3/14 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	21.4% 3/14 • Number of events 9 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	21.4% 3/14 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	28.6% 4/14 • Number of events 11 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 3/6 • Number of events 7 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	60.0% 3/5 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	35.7% 5/14 • Number of events 9 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Nausea	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	42.9% 6/14 • Number of events 8 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Edema limbs	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations INR increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Immune system disorders Allergic reaction	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	7.1% 1/14 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	28.6% 4/14 • Number of events 9 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	0.00% 0/6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	60.0% 3/5 • Number of events 9 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Fatigue	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	35.7% 5/14 • Number of events 7 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	60.0% 3/5 • Number of events 5 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	35.7% 5/14 • Number of events 6 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	80.0% 4/5 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
General disorders Fever	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 7/14 • Number of events 12 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 7/14 • Number of events 14 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	50.0% 3/6 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	20.0% 1/5 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Platelet count decreased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 1/3 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	64.3% 9/14 • Number of events 12 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	16.7% 1/6 • Number of events 1 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	40.0% 2/5 • Number of events 2 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	66.7% 2/3 • Number of events 3 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	78.6% 11/14 • Number of events 16 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	33.3% 2/6 • Number of events 4 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.	100.0% 5/5 • Number of events 7 • Approximately 3 years after start of treatment Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Per Section 7 of the protocol, all adverse events grades 3 through 4 and deaths, regardless of attribution to study drug, were collected, and adverse events grades 1 and 2 were to be recorded only if the attribution was at least possibly related to study drug. Of note, all deaths on this study were due to disease. All eligible patients are included in adverse event reporting.

Additional Information

Catherine Billups

PediatricBTC

Phone: 901-595-3370

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place