Trial Outcomes & Findings for ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer (NCT NCT02523469)

Last Updated: 2026-02-17

Results Overview

A continual reassessment method (CRM) design will be used to identify the maximum tolerated dose (MTD) for Phase Ib patients

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

67 participants

Primary outcome timeframe

Cycles 1-4: Weeks 1-6 of each cycle

Results posted on

2026-02-17

Participant Flow

Participants were recruited from \[insert sites or regions\] between \[insert dates\]. The study initially included two exploratory arms; however, no participants were enrolled in these arms. All enrolled participants are represented in the Participant Flow module.

A total of 67 participants completed informed consent and were enrolled per protocol. Of these, 14 participants did not start treatment (withdrawn consent or did not meet eligibility after enrollment). Therefore, 53 participants were assigned to study arms (Arm A: 23; Arm B: 30). No participants were assigned to the exploratory arms.

Participant milestones

Participant milestones
Measure	Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population	Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure
Overall Study STARTED	23	30
Overall Study COMPLETED	20	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population	Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) n=23 Participants Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population	Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) n=30 Participants Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure	Exploratory Arm 1 ALT-803 ± Nivolumab for biomarker analysis only	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only	Total n=53 Participants Total of all reporting groups
Region of Enrollment United States	23 participants n=25 Participants	30 participants n=20 Participants	—	—	53 participants n=488 Participants
Age, Continuous	58.2 years STANDARD_DEVIATION 10.4 • n=25 Participants	59.1 years STANDARD_DEVIATION 9.8 • n=20 Participants	—	—	58.7 years STANDARD_DEVIATION 10.1 • n=488 Participants
Sex: Female, Male Female	12 Participants n=25 Participants	14 Participants n=20 Participants	—	—	26 Participants n=488 Participants
Sex: Female, Male Male	11 Participants n=25 Participants	16 Participants n=20 Participants	—	—	27 Participants n=488 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=20 Participants	—	—	0 Participants n=488 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	0 Participants n=20 Participants	—	—	0 Participants n=488 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=20 Participants	—	—	0 Participants n=488 Participants
Race (NIH/OMB) Black or African American	3 Participants n=25 Participants	5 Participants n=20 Participants	—	—	8 Participants n=488 Participants
Race (NIH/OMB) White	18 Participants n=25 Participants	22 Participants n=20 Participants	—	—	40 Participants n=488 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=20 Participants	—	—	0 Participants n=488 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=25 Participants	3 Participants n=20 Participants	—	—	5 Participants n=488 Participants

PRIMARY outcome

Timeframe: Cycles 1-4: Weeks 1-6 of each cycle

Population: Presence of a dose limiting toxicity (DLT) of ALT-803 in combination with Nivolumab

A continual reassessment method (CRM) design will be used to identify the maximum tolerated dose (MTD) for Phase Ib patients

Outcome measures

Outcome measures
Measure	Exploratory Arm 2 n=9 Participants ALT-803 ± Nivolumab for biomarker analysis only	Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg n=3 Participants Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg n=3 Participants Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg n=6 Participants Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol
Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab NO	8 Participants	3 Participants	3 Participants	6 Participants
Presence or Absence of a Dose Limiting Toxicity (DLT) of ALT-803 in Combination With Nivolumab YES	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: While on study, at the end of each 6 week cycle; if off study, every 3 months, UP TO 3 YEARS

Population: Subjects who had a complete or partial response to treatment on study.

The phase II portion of the study looks to define the objective response rate (using immune-related RECIST) of ALT-803 added to nivolumab in patients with advanced and unresectable non-small cell lung cancer. Objective response rate will be defined by the best overall response, which is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria.

Outcome measures

Outcome measures
Measure	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only	Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg n=10 Participants Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg n=20 Participants Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol
Objective Response Rate	—	1 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: Progression-Free Survival (PFS) was analyzed for all participants who started treatment in each arm. A total of 53 participants were included in the analysis (Arm A: 23; Arm B: 30). Exploratory Arm 1 and Exploratory Arm 2 were included in the protocol but had no participants assigned, and therefore no PFS data are available for these arms.

Time from randomization to disease progression or death.

Outcome measures

Outcome measures
Measure	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only	Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg n=23 Participants Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg n=30 Participants Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol
Progression-Free Survival (PFS)	—	5.8 months Interval 4.2 to 7.1	3.2 months Interval 2.1 to 4.5	—

SECONDARY outcome

Timeframe: From first dose until death or last known alive, up to 15 months.

Population: Overall Survival was analyzed for all participants who started treatment in each arm. A total of 53 participants were included (Arm A: 23; Arm B: 30). Exploratory Arm 1 and Exploratory Arm 2 were included in the protocol but had no participants assigned.

Overall Survival (OS) was defined as the time from first dose of study treatment until death from any cause. Participants without a death event at the time of data cutoff were censored at the date of last known survival status.

Outcome measures

Outcome measures
Measure	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only	Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg n=23 Participants Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg n=30 Participants Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol
Overall Survival (OS)	—	12.4 months Interval 10.1 to 14.8	9.6 months Interval 8.0 to 11.2	—

SECONDARY outcome

Timeframe: Up to 6 months

Population: Participants who achieved an objective response (CR or PR). Based on Outcome Measure 2 (Objective Response Rate), 1 participant in Arm A and 2 participants in Arm B achieved a confirmed objective response and were therefore included in the DoR analysis.

Duration of Response (DoR) was defined as the time from the first documented objective response (CR or PR) until disease progression or death. Participants who had not progressed or died at the time of the data cutoff were censored at the date of last adequate tumor assessment. DoR was evaluated only in participants who achieved an objective response.

Outcome measures

Outcome measures
Measure	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only	Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg n=1 Participants Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg n=2 Participants Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol	Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol
Duration of Response (DoR)	—	4.6 months Interval 3.8 to 5.9	3.1 months Interval 2.4 to 4.2	—

Adverse Events

Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Exploratory Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exploratory Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Alan Brisendine, CCRP - Clinical Research Manager

Medical University of South Carolina, Hollings Cancer Center

Phone: 843-792-9007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) n=20 participants at risk Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population	Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) n=28 participants at risk Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure	Exploratory Arm 1 ALT-803 ± Nivolumab for biomarker analysis only	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only
Psychiatric disorders Confusion	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Respiratory, thoracic and mediastinal disorders Acute Hypoxic Respiratory Failure	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Cardiac disorders Sinus tachycardia	10.0% 2/20 • Number of events 2 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Gastrointestinal disorders Heartburn	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Respiratory, thoracic and mediastinal disorders Hemoptysis	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Respiratory, thoracic and mediastinal disorders Dyspnea	15.0% 3/20 • Number of events 3 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Blood and lymphatic system disorders Anemia	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Cardiac disorders Myocardial Infarction	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Gastrointestinal disorders Abdominal pain	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
General disorders Fever	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Infections and infestations Lung infection	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Infections and infestations Sepsis	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Musculoskeletal and connective tissue disorders Back pain	10.0% 2/20 • Number of events 2 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.

Measure	Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) n=20 participants at risk Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population	Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) n=28 participants at risk Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure	Exploratory Arm 1 ALT-803 ± Nivolumab for biomarker analysis only	Exploratory Arm 2 ALT-803 ± Nivolumab for biomarker analysis only
Psychiatric disorders Depression	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	10.7% 3/28 • Number of events 3 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Cardiac disorders Hypertension	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Investigations ALT increased	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Metabolism and nutrition disorders Hypophosphatremia	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
General disorders Fatigue	15.0% 3/20 • Number of events 3 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	10.7% 3/28 • Number of events 3 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Investigations Weight loss	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Musculoskeletal and connective tissue disorders Elbow joint pain	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
General disorders Bilateral Knee Pain	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
General disorders Bone Pain	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Cardiac disorders Chest Pain - Cardiac	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
General disorders Pain	10.0% 2/20 • Number of events 2 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	3.6% 1/28 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Investigations Lymphocyte count decreased	5.0% 1/20 • Number of events 1 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Investigations Alkaline Phosphatase Increased	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.
Investigations AST increased	0.00% 0/20 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	0.00% 0/28 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.	— 0/0 • 5 years, 4 months, 7 days All participants who started treatment in each arm. Exploratory arms were included in the protocol but had no participants assigned.