Trial Outcomes & Findings for CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study (NCT NCT04552704)

NCT ID: NCT04552704

Last Updated: 2023-08-02

Results Overview

Number of Participants with New Adverse Event (AE) of Grade \>= 3 (Phase I)

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: At day 60
• Results posted on: 2023-08-02

Participant Flow

The study was terminated by the sponsor after 3 out of 6 patients enrolled in phase I study.

Participant milestones

Measure	Phase I Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study

Baseline characteristics by cohort

Measure	Phase I (CD24Fc) n=3 Participants Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care (i.e., steroids per treating physician and best supportive care) in the absence of disease progression or unacceptable toxicity. CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV	Phase II, Arm I (CD24Fc) Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity. CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc: Given IV	Phase II, Arm II (Placebo) Patients receive placebo IV over 60 minutes on days 1, 14, and 28 in addition to standard of care treatment for irAE in the absence of disease progression or unacceptable toxicity. Placebo Administration: Given IV	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	—	3 participants n=4 Participants

PRIMARY outcome

Timeframe: At day 60

Number of Participants with New Adverse Event (AE) of Grade >= 3 (Phase I)

Outcome measures

Measure	Phase I n=3 Participants Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Number of Participants With New Adverse Event (AE) of Grade >= 3 (Phase I)	1 Participants

PRIMARY outcome

Timeframe: At day 42

Population: Study was terminated during Phase 1 portion of study.

Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 1 year

Population: Study was terminated during Phase 1 portion of study.

Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Time to irAE reduction by at least 1 grade from the initiation of CD24Fc treatment.

Outcome measures

Measure	Phase I n=3 Participants Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Time to irAE Reduction by at Least 1 Grade From the Initiation of CD24Fc Treatment (Phase I)	14 days Interval 14.0 to 14.0

SECONDARY outcome

Timeframe: Up to 2 weeks

Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase I)

Outcome measures

Measure	Phase I n=3 Participants Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Time to All irAEs Reduced to =< 1 From the Initiation of CD24Fc Treatment (Phase I)	14 days Interval 14.0 to 14.0

SECONDARY outcome

Timeframe: Up to about 3.5 months

Time to resume immune check point inhibitor (ICI) treatment from the initiation of CD24Fc treatment (Phase I)

Outcome measures

Measure	Phase I n=2 Participants Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Time to Resume Immune Check Point Inhibitor (ICI) Treatment From the Initiation of CD24Fc Treatment (Phase I)	84.5 days Interval 61.0 to 108.0

SECONDARY outcome

Timeframe: At day 42

The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients.

Outcome measures

Measure	Phase I n=3 Participants Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Recovery Rate (Reduction of irAE by One Grade) (Phase I)	100 percentage of participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Study was terminated during Phase 1 portion of study. No data collected for Phase 2.

Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase II)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Population: Study was terminated during Phase 1 portion of study. No data collected for Phase 2.

Summary of use of steroids and other treatment for irAE.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year

Population: Study was terminated during Phase 1 portion of study. No data collected for Phase 2.

The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 year

Population: Study was terminated during Phase 1 portion of study. No data collected for Phase 2.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to death, assessed up to 1 year

Population: Study was terminated during Phase 1 portion of study. No data collected for Phase 2.

Count of participants known to be alive up to 1 year from the time from start of treatment.

Outcome measures

Outcome data not reported

Adverse Events

Phase I

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Phase I n=3 participants at risk Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Gastrointestinal disorders Odynophagia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
General disorders Fever	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.

Other adverse events

Measure	Phase I n=3 participants at risk Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Blood bicarbonate decreased	100.0% 3/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Blood bilirubin increased	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
General disorders Fatigue	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Infections and infestations Hepatic infection	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Metabolism and nutrition disorders Hyponatremia	66.7% 2/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	66.7% 2/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Infections and infestations Infections and infestations - ascending thoracic aneurysm	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Infections and infestations Infections and infestations - BUN decreased	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Infections and infestations Infections and infestations - tachypnea	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Lymphocyte count decreased	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Platelet count decreased	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations White blood cell decreased	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Alanine aminotransferase increased	66.7% 2/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Aspartate aminotransferase increased	66.7% 2/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Blood and lymphatic system disorders Palor	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Gastrointestinal disorders Heart burn	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations Elevated neutrophil	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations GGT elevated	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Investigations WBC elevated	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New lingular plueral-based opacity with increased FDG	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Possible new segment 2 metastatic lesion	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Respiratory, thoracic and mediastinal disorders Left vocal chord paralysis	33.3% 1/3 • Up to 60 days All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.

Additional Information

Analyst

University of California, Davis

Phone: 916-734-8053

Email: nlogihara@ucdavis.edu

Results disclosure agreements

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