Trial Outcomes & Findings for Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer (NCT NCT04373369)

Last Updated: 2025-11-03

Results Overview

* Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study.) In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) * Kaplan-Meier product limit estimator will be used to estimate progression-free survival (PFS) at 6 months, with the inclusion of 90% confidence interval.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2025-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Vorolanib + Atezolizumab Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vorolanib + Atezolizumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vorolanib + Atezolizumab n=11 Participants Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Age, Continuous	65 years n=3 Participants
Sex: Female, Male Female	4 Participants n=3 Participants
Sex: Female, Male Male	7 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	0 Participants n=3 Participants
Race (NIH/OMB) White	10 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants
Region of Enrollment United States	11 participants n=3 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Vorolanib + Atezolizumab n=11 Participants Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Kaplan Meier Estimate of Progression-free Survival (PFS) at 6 Months	27.3 percentage of participants-Kaplan Meier Interval 8.9 to 49.8

SECONDARY outcome

Timeframe: Through completion of follow-up for progression-free survival (median length of follow-up 81 days, full range 25-1526 days)

Outcome measures

Outcome measures
Measure	Vorolanib + Atezolizumab n=11 Participants Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Median Progression-free Survival (PFS)	2.7 months Interval 1.3 to 5.1

SECONDARY outcome

Timeframe: Through completion of follow-up (median length of follow-up 446 days, full range 93-1526 days)

Overall survival is defined as the length of time from the start of study treatment that patients diagnosed with the disease are still alive.

Outcome measures

Outcome measures
Measure	Vorolanib + Atezolizumab n=11 Participants Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Median Overall Survival	14.6 months Interval 5.1 to 16.7

SECONDARY outcome

Timeframe: From the start of treatment until 90 days after completion of treatment (median length of follow-up 165 days, full range 93-527 days).

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

Outcome measures

Outcome measures
Measure	Vorolanib + Atezolizumab n=11 Participants Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 periorbital edema	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 bloating	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 constipation	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 diarrhea	5 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 toothache	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 edema limbs	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 alkaline phosphatase	4 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 aspartate aminotransferase increased	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 aspartate aminotransferase increased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 blood bilirubin increased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 blood lactate dehydrogenase increased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 creatinine increased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 INR increased	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 lipase increased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 lymphocyte count decreased	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 anorexia	4 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hyperglycemia	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypertriglyceridemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypoalbuminemia	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypocalcemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 hypocalcemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypoglycemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 flank pain	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 generalized muscle weakness	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 generalized muscle weakness	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 paresthesia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 seizure	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 insomnia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 proteinuria	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 orthopnea	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 epistaxis	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 hypoxia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 dry skin	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hair color changes	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 generalized weakness	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 chills	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 fatigue	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 fatigue	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 fever	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 gait disturbance	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 malaise	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 malaise	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 allergic reaction (poison sumac)	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 COVID-19 infection	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 urinary tract infection	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 lung infection	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 sepsis	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 thrush	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 sunburn	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 bruising	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 neutrophil count decreased	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 neutrophil count decreased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 transaminitis	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 activated partial thromboplastin time prolonged	4 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 alanine aminotransferase increased	5 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 alanine aminotransferase increased	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 platelet count decreased	5 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-4 platelet count decreased	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 white blood cell decreased	4 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 malnutrition	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypokalemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 hypokalemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hyponatremia	4 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 hyponatremia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 groin pain	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 groin pain	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 muscle aches	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 arthralgia	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 back pain	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 dizziness	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 headache	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 chronic kidney disease (decreased eGFR)	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 glucosuria	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hematuria	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 acute hypoxemic respiratory failure	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 allergic rhinitis	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 cough	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 dyspnea	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 dyspnea	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 pleural effusion	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 rhinorrhea	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 sore throat	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 rash maculo-papular	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 alopecia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 pruritus	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypertension	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 hypertension	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 hypotension	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 hypotension	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 sinus tachycardia	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 vertigo	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 adrenal insufficiency	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 allergic conjunctivitis (discharge from eyes due to allergies)	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 bilateral eye drainage - intermittent	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 anemia	9 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 anemia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 eosinophilia	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 leukocytosis	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 teeth sensitivity	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 abdominal pain	2 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 diarrhea	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 dry mouth	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 nausea	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 nausea	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 typhitis	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 vomiting	3 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 3-5 vomiting	1 Participants
Safety and Tolerability of Treatment Regimen as Measured by the Number of Participants With Adverse Events Grade 1-2 non cardiac chest pain	1 Participants

Adverse Events

Vorolanib + Atezolizumab

Serious events: 3 serious events

Other events: 11 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Vorolanib + Atezolizumab n=11 participants at risk Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Endocrine disorders Adrenal insufficiency	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Nausea	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Vomiting	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Fatigue	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Malaise	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Infections and infestations Lung infection	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Platelet count decreased	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Vascular disorders Hypotension	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).

Other adverse events

Other adverse events
Measure	Vorolanib + Atezolizumab n=11 participants at risk Consenting and eligible participants who have no evidence of tumor progression after 3 to 4 cycles of standard-of-care induction therapy will receive atezolizumab intravenously (IV) every 3 weeks and vorolanib by mouth daily.
Gastrointestinal disorders Toothache	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Typhilitis	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Blood and lymphatic system disorders Anemia	90.9% 10/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Blood and lymphatic system disorders Eosinophilia	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Blood and lymphatic system disorders Leukocytosis	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Cardiac disorders Sinus tachycardia	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Ear and labyrinth disorders Vertigo	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Eye disorders Allergic conjunctivitis (discharge from eyes due to allergies)	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Eye disorders Bilateral eye drainage - intermitten	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Eye disorders Periorbital edema	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Abdominal pain	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Bloating	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Constipation	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Diarrhea	54.5% 6/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Dry mouth	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Nausea	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Teeth sensitivity	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Gastrointestinal disorders Vomiting	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Chills	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Edema limb	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Fatigue	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Fever	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Gait disturbance	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Generalized weakness	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Malaise	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
General disorders Non-cardiac chest pain	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Immune system disorders Allergic reaction (poison sumac)	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Infections and infestations COVID-19 infection	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Infections and infestations Sepsis	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Infections and infestations Thrush	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Infections and infestations Urinary tract infection	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Injury, poisoning and procedural complications Bruising	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Injury, poisoning and procedural complications Sunburn	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Activated partial thromboplastin time prolonged	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Alanine aminotransferase increased	54.5% 6/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Alkaline phosphatase increased	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Aspartate aminotransferase increased	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Blood bilirubin increased	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Blood lactate dehydrogenase increased	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Creatinine increased	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations INR increased	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Lipase increased	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Lymphocyte count decreased	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Neutrophil count decreased	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Platelet count decreased	54.5% 6/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Transaminitis	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations Weight loss decreased	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Investigations White blood cell decreased	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Anorexia	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Hyperglycemia	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Hypertriglyceridemia	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Hypoalbuminemia	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Hypocalcemia	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Hypoglycemia	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Hyponatremia	45.5% 5/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Metabolism and nutrition disorders Malnutrition	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Musculoskeletal and connective tissue disorders Arthralgia	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Musculoskeletal and connective tissue disorders Flank pain	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Musculoskeletal and connective tissue disorders Groin pain	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Musculoskeletal and connective tissue disorders Muscle aches	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Nervous system disorders Dizziness	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Nervous system disorders Headache	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Nervous system disorders Paresthesia	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Nervous system disorders Seizure	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Psychiatric disorders Insomnia	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Renal and urinary disorders Chronic kidney disease (decreased eGFR)	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Renal and urinary disorders Glucosuria	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Renal and urinary disorders Hematuria	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Renal and urinary disorders Proteinuria	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Acute hypoxemic respiratory failure	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Cough	27.3% 3/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Hypoxia	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Orthopnea	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Respiratory, thoracic and mediastinal disorders Sore throat	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Skin and subcutaneous tissue disorders Alopecia	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Skin and subcutaneous tissue disorders Dry skin	18.2% 2/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Skin and subcutaneous tissue disorders Hair color changes	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Vascular disorders Hypertension	36.4% 4/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).
Vascular disorders Hypotension	9.1% 1/11 • Adverse events were collected from start of treatment through 90 days after end of treatment (median 165 days, full range 93-527 days). All-cause mortality was followed up to 3 years after discontinuation of study treatment (median 446 days, full range 93-1526 days).

Additional Information

Daniel Morgensztern, M.D.

Washington University School of Medicine

Phone: 314-362-5817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place