Trial Outcomes & Findings for 9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma (NCT NCT05010629)

Last Updated: 2026-08-07

Results Overview

ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.

Results posted on

2026-08-07

Participant Flow

Participants were enrolled from 9/17/2021 to 4/12/2024.

Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.

Participant milestones

Participant milestones
Measure	9-ING-41 + Carboplatin (Part I) Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Overall Study STARTED	16	16
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	16	16

Reasons for withdrawal

Reasons for withdrawal
Measure	9-ING-41 + Carboplatin (Part I) Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Overall Study Physician Decision	2	3
Overall Study Progressive Disease	9	11
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	Total n=32 Participants Total of all reporting groups
Age, Continuous	63.5 Years STANDARD_DEVIATION 13.6 • n=20 Participants	63.6 Years STANDARD_DEVIATION 9.0 • n=20 Participants	63.5 Years STANDARD_DEVIATION 11.3 • n=40 Participants
Sex: Female, Male Female	13 Participants n=20 Participants	7 Participants n=20 Participants	20 Participants n=40 Participants
Sex: Female, Male Male	3 Participants n=20 Participants	9 Participants n=20 Participants	12 Participants n=40 Participants
Race/Ethnicity, Customized American Indian	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized Asian	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized Black/African American	1 Participants n=20 Participants	1 Participants n=20 Participants	2 Participants n=40 Participants
Race/Ethnicity, Customized White	15 Participants n=20 Participants	12 Participants n=20 Participants	27 Participants n=40 Participants
Race/Ethnicity, Customized Other	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants

PRIMARY outcome

Timeframe: Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.

Population: According to the protocol, all evaluable patients were combined for the primary analysis.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=32 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Objective Response Rate (ORR)	—	9.4 percentage of participants Interval 2.0 to 25.0

SECONDARY outcome

Timeframe: Tumor assessments were performed every 9 weeks for up to 20.2 months.

PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Median Progression Free Survival (PFS)	7.3 Months Interval 1.9 to 11.4	4.3 Months Interval 2.1 to 12.5

SECONDARY outcome

Timeframe: Up to 38.1 months

Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Median Overall Survival (OS)	NA Months Interval 9.7 to Median OS was not reached. The upper bound of the OS confidence interval is not available due to insufficient observed events at this time.	15.6 Months Interval 5.4 to 27.8

SECONDARY outcome

Timeframe: Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.

Population: Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The analysis dataset is comprised of all participants with measurable disease at baseline who achieved objective response on treatment. No responders among Part I participants.

DOR is defined as the time from date of first documented confirmed objective response to date of first documented progressive disease (PD). Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=3 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Duration of Response (DOR)	—	6.9 months Interval 2.2 to 7.3

SECONDARY outcome

Timeframe: AEs were assessed at Day 1 and Day 4 of each 21-day treatment cycle; assessed for up to 16.6 months.

Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Number of Participants With Treatment Related Adverse Events (AE)	15 participants	16 participants

SECONDARY outcome

Timeframe: Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.

Population: Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point

UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL) At baseline	48.1 score on a scale Standard Deviation 40.1	51.7 score on a scale Standard Deviation 38.3
Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL) At off-treatment	56.2 score on a scale Standard Deviation 32	32.1 score on a scale Standard Deviation 37.4

SECONDARY outcome

Timeframe: Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.

Population: Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.

UW-QOL Global Question 2 assessed patients' health-related QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Mean Score of Global Question 2 in UW-QOL At baseline	58.5 score on a scale Standard Deviation 23.8	48.8 score on a scale Standard Deviation 24.2
Mean Score of Global Question 2 in UW-QOL At off-treatment	40.0 score on a scale Standard Deviation 18.5	42.9 score on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.

Population: Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype. The number analyzed for each row reflects the number of participants who completed the question at the corresponding time point.

UW-QOL Global Question 3 assessed patients' overall QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding.

Outcome measures

Outcome measures
Measure	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 Participants Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.	9-ING-41 + Carboplatin (Part I) n=16 Participants Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Mean Score of Global Question 3 in UW-QOL At baseline	61.3 score on a scale Standard Deviation 19.7	55 score on a scale Standard Deviation 29.7
Mean Score of Global Question 3 in UW-QOL At off-treatment	57.5 score on a scale Standard Deviation 24.9	53.3 score on a scale Standard Deviation 30.1

Adverse Events

9-ING-41 + Carboplatin (Part I)

Serious events: 10 serious events

Other events: 16 other events

Deaths: 12 deaths

Pembrolizumab + 9-ING-41 + Carboplatin (Part II)

Serious events: 8 serious events

Other events: 16 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Glenn J. Hanna

Dana-Farber Cancer Institute

Phone: 617-632-3090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	9-ING-41 + Carboplatin (Part I) n=16 participants at risk Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 participants at risk Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
Blood and lymphatic system disorders Anemia	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Atrial flutter	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Dysphagia	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Nausea	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Oral hemorrhage	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Pancreatitis	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Vomiting	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Death NOS	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Disease progression	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Edema face	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Edema limbs	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Fever	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Infections and infestations Infections and infestations - Other, specify	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Infections and infestations Lung infection	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Infections and infestations Sepsis	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Infections and infestations Urinary tract infection	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Injury, poisoning and procedural complications Fall	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Injury, poisoning and procedural complications Fracture	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Injury, poisoning and procedural complications Hip fracture	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Injury, poisoning and procedural complications Infusion related reaction	25.0% 4/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Injury, poisoning and procedural complications Spinal fracture	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Investigations Blood bilirubin increased	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Investigations Lipase increased	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Investigations Platelet count decreased	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Metabolism and nutrition disorders Dehydration	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Metabolism and nutrition disorders Hyponatremia	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Renal and urinary disorders Acute kidney injury	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Respiratory, thoracic and mediastinal disorders Dyspnea	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Respiratory, thoracic and mediastinal disorders Hypoxia	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).

Other adverse events
Measure	9-ING-41 + Carboplatin (Part I) n=16 participants at risk Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.	Pembrolizumab + 9-ING-41 + Carboplatin (Part II) n=16 participants at risk Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year. Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
Blood and lymphatic system disorders Anemia	100.0% 16/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	100.0% 16/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Blood and lymphatic system disorders Febrile neutropenia	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	25.0% 4/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Atrial fibrillation	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Atrioventricular block first degree	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Cardiac disorders - Other, specify	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Chest pain - cardiac	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Heart failure	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Sinus bradycardia	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Cardiac disorders Sinus tachycardia	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Ear and labyrinth disorders Ear pain	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Ear and labyrinth disorders Hearing impaired	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	31.2% 5/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Ear and labyrinth disorders Tinnitus	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	37.5% 6/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Ear and labyrinth disorders Vertigo	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Endocrine disorders Adrenal insufficiency	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Endocrine disorders Endocrine disorders - Other, specify	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Endocrine disorders Hypothyroidism	43.8% 7/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	50.0% 8/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Eye disorders Blurred vision	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Eye disorders Eye disorders - Other, specify	100.0% 16/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	37.5% 6/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Eye disorders Glaucoma	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Eye disorders Photophobia	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Eye disorders Vision decreased	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Eye disorders Watering eyes	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Bloating	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Constipation	75.0% 12/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	81.2% 13/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Diarrhea	25.0% 4/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Dry mouth	75.0% 12/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	68.8% 11/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Dyspepsia	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Dysphagia	31.2% 5/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	25.0% 4/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Gastroesophageal reflux disease	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	56.2% 9/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Mucositis oral	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Nausea	75.0% 12/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	100.0% 16/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Oral pain	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Pancreatitis	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Tooth development disorder	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
Gastrointestinal disorders Vomiting	43.8% 7/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Edema face	0.00% 0/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	6.2% 1/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).
General disorders Edema limbs	12.5% 2/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).	18.8% 3/16 • Adverse events were followed up to 16.6 months. Survival status was followed up to 38.1 months. Serious adverse events (SAEs) include: death; life-threatening events (immediate risk of death); events requiring or prolonging hospitalization; persistent/significant disability; congenital anomalies; important medical events that may jeopardize the participant or require intervention to prevent serious outcomes; and suspected transmission of infectious agents via the study drug. All other remaining AEs were included in other adverse events (OAEs).