Trial Outcomes & Findings for Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma (NCT NCT03389477)

Last Updated: 2026-04-21

Results Overview

* Tumor response rate is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) based on RECIST criteria * CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

2 cycles (56 days)

Results posted on

2026-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT
Step 1 STARTED	19	7
Step 1 COMPLETED	18	7
Step 1 NOT COMPLETED	1	0
Step 2 STARTED	18	7
Step 2 COMPLETED	16	3
Step 2 NOT COMPLETED	2	4
Step 3 STARTED	16	3
Step 3 COMPLETED	11	2
Step 3 NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT
Step 1 Withdrawal by Subject	1	0
Step 2 Withdrawal by Subject	1	2
Step 2 Disease progression	1	0
Step 2 Death	0	1
Step 2 Poor performance status and nutrition	0	1
Step 3 Withdrawal after 3 cycles	0	1
Step 3 Still receiving active treatment	4	0
Step 3 Progressive disease after 2 cycles	1	0

Baseline Characteristics

Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib n=19 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib n=7 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT	Total n=26 Participants Total of all reporting groups
Age, Continuous	61 years n=13 Participants	66 years n=13 Participants	63 years n=26 Participants
Sex: Female, Male Female	4 Participants n=13 Participants	3 Participants n=13 Participants	7 Participants n=26 Participants
Sex: Female, Male Male	15 Participants n=13 Participants	4 Participants n=13 Participants	19 Participants n=26 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=13 Participants	7 Participants n=13 Participants	26 Participants n=26 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Asian	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Black or African American	3 Participants n=13 Participants	1 Participants n=13 Participants	4 Participants n=26 Participants
Race (NIH/OMB) White	16 Participants n=13 Participants	6 Participants n=13 Participants	22 Participants n=26 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants	0 Participants n=13 Participants	0 Participants n=26 Participants
Region of Enrollment United States	19 participants n=13 Participants	7 participants n=13 Participants	26 participants n=26 Participants

PRIMARY outcome

Timeframe: 2 cycles (56 days)

Population: The data for Cohort 1 and Cohort 2 were combined as the participants enrolled in both cohorts received the same neoadjuvant palbociclib treatment (125 mg/day Days 1-21 of a 28-day cycle for two cycles) in Step 1.

Outcome measures

Outcome measures
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib n=26 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT
Tumor Response Rate of Newly Diagnosed p16INK4a Negative, HPV-unrelated HNSCC to Neoadjuvant Palbociclib Monotherapy	6 Participants	—

SECONDARY outcome

Timeframe: Through 18 months after completion of step 2

* Local-regional disease relapse, a binary variable (Yes vs. No). Local-regional disease relapse rate is defined as the proportion of subjects alive who have local-regional progressed disease at 18 months following completion of CRT, stratified by cohorts. * Distant metastases, a binary variable (Yes vs. No). Distant metastases rate is defined as the proportion of subjects alive who have distant metastases at 18 months following completion of CRT, stratified by cohorts.

Outcome measures

Outcome measures
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib n=18 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib n=7 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT
Combined Local-regional Disease Relapse Risk and Distant Metastases Risk Following Completion of CRT Local-regional disease relapse	0 Participants	2 Participants
Combined Local-regional Disease Relapse Risk and Distant Metastases Risk Following Completion of CRT Distant metastases	4 Participants	1 Participants
Combined Local-regional Disease Relapse Risk and Distant Metastases Risk Following Completion of CRT Both local-regional disease relapse and distant metastases	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Through 5 years after completion of step 2

-Progression-free survival (PFS), defined as the interval from the start of Step 2 (CRT) to the first documentation of disease progression or death from any cause or the end of follow-up, stratified by cohorts.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 2 years after completion of step 2

-Progression-free survival (PFS), defined as the days from the start of Step 2 (CRT) to the first documentation of disease progression or death from any cause or the end of follow-up

Outcome measures

Outcome measures
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib n=18 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib n=7 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT
Progression-free Survival (PFS) of Patients Treated With the Three Step Sequence of Palbociclib Monotherapy, CRT, and Adjuvant Palbociclib Monotherapy	13 Participants	3 Participants

SECONDARY outcome

Timeframe: Through 5 years after completion of step 2

-Overall survival (OS), defined as the days from the time of diagnosis to death from any cause or the end of follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 2 years after completion of step 2

-Overall survival (OS), defined as the days from the time of diagnosis to death from any cause or the end of follow-up

Outcome measures

Outcome measures
Measure	Cohort 1: 1: Palbociclib, 2: Cisplatin & IMRT, 3: Palbociclib n=18 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cisplatin \& IMRT	Cohort 2: 1: Palbociclib, 2: Cetuximab & IMRT, 3: Palbociclib n=7 Participants * Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles) * Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks * Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT
Overall Survival of Patients Treated With the Three Step Sequence of Palbociclib Monotherapy, CRT, and Adjuvant Palbociclib Monotherapy	16 Participants	5 Participants

SECONDARY outcome

Timeframe: At baseline and at time of disease relapse (up to 5 years)

Tumor genomic alterations at baseline and at relapse will be compared to assess for potential mechanisms of primary or secondary resistance to palbociclib.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and at time of disease relapse (up to 5 years)

Number of participants with altered versus wild-type at baseline will be compared with response.

Outcome measures

Outcome data not reported

Adverse Events

Step 1 Neoadjuvant Palbociclib for Cohort 1 and Cohort 2

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Step 2 Cohort 1 (Cisplatin + IMRT)

Serious events: 10 serious events

Other events: 18 other events

Deaths: 0 deaths

Step 2 Cohort 2 (Cetuximab + IMRT)

Serious events: 4 serious events

Other events: 7 other events

Deaths: 1 deaths

Step 3 Adjuvant Palbociclib for Cohort 1 and Cohort 2

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Follow-up After Completion of Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Step 1 Neoadjuvant Palbociclib for Cohort 1 and Cohort 2 n=26 participants at risk -Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles)	Step 2 Cohort 1 (Cisplatin + IMRT) n=18 participants at risk -Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks	Step 2 Cohort 2 (Cetuximab + IMRT) n=7 participants at risk -Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks	Step 3 Adjuvant Palbociclib for Cohort 1 and Cohort 2 n=19 participants at risk -Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT	Follow-up After Completion of Treatment -Follow-up after completion of treatment.
Blood and lymphatic system disorders Anemia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Diarrhea	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Dysphagia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Mucositis oral	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Fever	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Catheter related infection	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Tracheitis	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Injury, poisoning and procedural complications Fall	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Creatinine increased	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Neutrophil count decreased	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Platelet count decreased	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Anorexia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hyperkalemia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Malabsorption	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Psychiatric disorders Delirium	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Renal and urinary disorders Acute kidney injury	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Aspiration	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Lung infection	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Stridor	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.

Other adverse events

Other adverse events
Measure	Step 1 Neoadjuvant Palbociclib for Cohort 1 and Cohort 2 n=26 participants at risk -Step 1: Neoadjuvant palbociclib monotherapy (125 mg/day, Days 1-21 of a 28-day cycle for two cycles)	Step 2 Cohort 1 (Cisplatin + IMRT) n=18 participants at risk -Step 2: Cisplatin 100 mg/m\^2 given on Days 1 and 22 with accelerated IMRT 70 Gy to be administered over 6 weeks	Step 2 Cohort 2 (Cetuximab + IMRT) n=7 participants at risk -Step 2: Cetuximab given one week before RT and then weekly with accelerated IMRT 70 Gy to be administered over 6 weeks	Step 3 Adjuvant Palbociclib for Cohort 1 and Cohort 2 n=19 participants at risk -Step 3: Adjuvant palbociclib 125 mg/day, days 1-21 of each 28-day cycle for six cycles. Adjuvant palbociclib will begin 16 to 22 weeks following completion of cetuximab \& IMRT	Follow-up After Completion of Treatment -Follow-up after completion of treatment.
Blood and lymphatic system disorders Anemia	88.5% 23/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	94.4% 17/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	85.7% 6/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	78.9% 15/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Cardiac disorders Sinus bradycardia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Cardiac disorders Sinus tachycardia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Ear and labyrinth disorders Ear pain	11.5% 3/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Ear and labyrinth disorders Hearing impaired	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Ear and labyrinth disorders Tinnitus	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Endocrine disorders Hyperthyroidism	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Eye disorders Cataract	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Abdominal pain	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Constipation	30.8% 8/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	72.2% 13/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Diarrhea	30.8% 8/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	38.9% 7/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Dry mouth	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	83.3% 15/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	71.4% 5/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	68.4% 13/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Dyspepsia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Dysphagia	73.1% 19/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	83.3% 15/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	52.6% 10/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Esophagitis	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Gastroesophageal reflux disease	19.2% 5/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Hemorrhoids	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Mucositis oral	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	61.1% 11/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	85.7% 6/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	26.3% 5/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Nausea	34.6% 9/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	66.7% 12/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	71.4% 5/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	21.1% 4/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Odynophagia	15.4% 4/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Oral hemorrhage	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Oral pain	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Gastrointestinal disorders Vomiting	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	50.0% 9/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Edema face	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Edema limbs	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Fatigue	42.3% 11/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	72.2% 13/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	85.7% 6/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.9% 11/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Fever	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Infusion related reaction	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Localized edema	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Non-cardiac chest pain	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
General disorders Pain	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Immune system disorders Allergic reaction (dressing adhesive)	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Bacteremia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations COVID-19	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Catheter related infection	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Lip infection	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Skin infection	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Tracheitis	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Upper respiratory infection	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Urinary tract infection	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Infections and infestations Vaginal infection	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	83.3% 15/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	71.4% 5/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	31.6% 6/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Injury, poisoning and procedural complications Fall	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Activated partial thromboplastin time prolonged	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Alanine aminotransferase increased	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Alkaline phosphatase increased	15.4% 4/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	22.2% 4/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Aspartate aminotransferase increased	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Blood bilirubin increased	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Cardiac troponin I increased	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Creatinine increased	11.5% 3/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	50.0% 9/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	31.6% 6/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Hemoglobin increased	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations INR increased	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Lymphocyte count decreased	57.7% 15/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	94.4% 17/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	85.7% 6/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	94.7% 18/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Neutrophil count decreased	76.9% 20/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	66.7% 12/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	89.5% 17/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Platelet count decreased	46.2% 12/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	72.2% 13/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	52.6% 10/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations Weight loss	26.9% 7/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	77.8% 14/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	52.6% 10/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Investigations White blood cell decreased	76.9% 20/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	94.4% 17/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	100.0% 19/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Anorexia	11.5% 3/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypercalcemia	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypercholesterolemia	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hyperkalemia	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	44.4% 8/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypoalbuminemia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	44.4% 8/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	71.4% 5/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypocalcemia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	44.4% 8/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypokalemia	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	44.4% 8/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypomagnesemia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hyponatremia	26.9% 7/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	55.6% 10/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	31.6% 6/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	27.8% 5/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.1% 4/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Metabolism and nutrition disorders Obesity	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Arthritis	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Back pain	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	50.0% 13/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Dizziness	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Dysarthria	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Dysgeusia	11.5% 3/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	61.1% 11/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	71.4% 5/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	57.9% 11/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Headache	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Paresthesia	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Nervous system disorders Tremor	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Psychiatric disorders Anxiety	19.2% 5/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Psychiatric disorders Confusion	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Psychiatric disorders Depression	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Psychiatric disorders Insomnia	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Renal and urinary disorders Acute kidney injury	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Renal and urinary disorders Chronic kidney disease	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Renal and urinary disorders Hematuria	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Renal and urinary disorders Proteinuria	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Renal and urinary disorders Urinary retention	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Reproductive system and breast disorders Ejaculation disorder	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Cough	11.5% 3/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	26.3% 5/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Dyspnea	19.2% 5/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	33.3% 6/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	31.6% 6/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Hoarseness	65.4% 17/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	26.3% 5/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	19.2% 5/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.5% 3/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	42.9% 3/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	21.1% 4/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Voice alteration	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Respiratory, thoracic and mediastinal disorders Wheezing	7.7% 2/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	16.7% 3/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	15.8% 3/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Dry skin	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	10.5% 2/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Pruritus (ocular)	3.8% 1/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	71.4% 5/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Rash pustular	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.6% 1/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	5.3% 1/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Vascular disorders Lymphedema	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	11.1% 2/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	28.6% 2/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	26.3% 5/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.
Vascular disorders Thromboembolic event	0.00% 0/26 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/18 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	14.3% 1/7 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	0.00% 0/19 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.	— 0/0 • Adverse events (AEs) collected for 56 days Step 1. Step 2 Cohort 1 & Cohort 2 collected 6 weeks. Step 3 collected from start of Step 3 through 30 days following the last day of treatment. If a patient went off treatment during Step 1 or Step 2, they were collected for an additional 30 days after treatment. Median AE follow-up 376.5 days (full range 61-486 days). Median all-cause mortality follow-up 596 days (full range 61 days-1573 days). Serious adverse events and adverse events were not collected during the long term follow-up.

Additional Information

Douglas Adkins, M.D.

Washington University School of Medicine

Phone: (314) 362-4471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place