Trial Outcomes & Findings for Ramucirumab and Atezolizumab After Progression on Any Immune Checkpoint Blocker in NSCLC (NCT NCT03689855)

NCT ID: NCT03689855

Last Updated: 2024-07-30

Results Overview

* ORR: percentage of participants with a complete or partial response * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: At 6 weeks
• Results posted on: 2024-07-30

Participant Flow

Participant milestones

Measure	Ramucirumab + Atezolizumab * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Ramucirumab + Atezolizumab * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ramucirumab and Atezolizumab After Progression on Any Immune Checkpoint Blocker in NSCLC

Baseline characteristics by cohort

Measure	Ramucirumab + Atezolizumab n=21 Participants * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 weeks

• ORR: percentage of participants with a complete or partial response
• Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
• Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Measure	Ramucirumab + Atezolizumab n=21 Participants * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Overall Response Rate (ORR)	1 Participants

SECONDARY outcome

Timeframe: At 6 weeks

• CBR is defined as the percentage of patients who have achieved responses (complete or partial) or stable disease.
• Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
• Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
• Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Measure	Ramucirumab + Atezolizumab n=21 Participants * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Clinical Benefit Rate (CBR)	16 Participants

SECONDARY outcome

Timeframe: Through 30 days after completion of treatment (estimated to be 4 months)

-Measured by NCI-CTCAE version 5.0.

Outcome measures

Measure	Ramucirumab + Atezolizumab n=21 Participants * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 somnolence	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 anemia	8 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 atrial fibrillation	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 pericardial effusion	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 ear pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypothyroidism	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 eye pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 abdominal pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 ascites	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 colitis	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 constipation	5 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 diarrhea	6 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dyspepsia	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dysphagia	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 mucositis oral	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 nausea	10 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 oral pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 stomach pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 vomiting	7 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 non-cardiac chest pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 chills	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 edema limbs	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 infusion related reaction	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 vascular access complication	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 alanine aminotransferase increased	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 alkaline phosphatase	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 aspartate aminotransferase increased	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 creatinine increased	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hemoglobin increased	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 lipase increased	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 lymphocyte count decreased	5 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 neutrophil count decreased	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 platelet count decreased	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 serum amylase increased	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 thyroid stimulating hormone increased	7 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 weight loss	5 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 weight loss	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 white blood cell decreased	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 anorexia	8 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 anorexia	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dehydration	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypercalcemia	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hyperglycemia	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hyperkalemia	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypoalbuminemia	6 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypocalcemia	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypoglycemia	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hyponatremia	6 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 hyponatremia	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hernia right groin	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 pain right groin	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 rib pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 arthralgia	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 flank pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 generalized muscle weakness	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 myalgia	5 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 neck pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 osteonecrosis of jaw	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 pain in extremity	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 bilateral vocal cord paralysis	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 right vocal fold paralysis	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 cognitive disturbance	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dizziness	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dysgeusia	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dysphasia	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 headache	9 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 memory impairment	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 peripheral motor neuropathy	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 peripheral sensory neuropathy	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 somnolence	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 stroke	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 transient ischemic attacks	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 anxiety	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 confusion	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 delirium	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 insomnia	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hematuria	4 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 proteinuria	12 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1 pelvic pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hemoptysis	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 allergic rhinitis	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 atelectasis	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 cough	8 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 dyspnea	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 dyspnea	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 epistaxis	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hiccups	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 nasal congestion	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 oropharyngeal pain	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 sore throat	2 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 alopecia	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hyperhidrosis	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 rash maculo-papular	1 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypertension	15 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 3-5 hypertension	3 Participants
Toxicity and Tolerability as Measured by Number of Participants Who Experienced Adverse Events Grade 1-2 hypotension	3 Participants

SECONDARY outcome

Timeframe: Through 2 years after completion of treatment (median length of follow-up 16.3 months, full range=2.3-45.6 months)

Outcome measures

Measure	Ramucirumab + Atezolizumab n=21 Participants * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Overall Survival (OS)	16.3 months Interval 7.1 to 20.9

SECONDARY outcome

Timeframe: Through 2 years after completion of treatment (median length of follow-up 16.3 months, full range=2.3-45.6 months)

-PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Outcome measures

Measure	Ramucirumab + Atezolizumab n=21 Participants * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Progression-free Survival (PFS)	1.0 months Interval 1.0 to 2.3

Adverse Events

Ramucirumab + Atezolizumab

Serious events: 10 serious events

Other events: 21 other events

Deaths: 15 deaths

Serious adverse events

Measure	Ramucirumab + Atezolizumab n=21 participants at risk * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Cardiac disorders Atrial fibrillation	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Cardiac disorders Pericardial effusion	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Ascites	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
General disorders Non-cardiac chest pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Hepatobiliary disorders Portal hypertension	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations COVID-19	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Urinary tract infection	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Injury, poisoning and procedural complications Infusion related reaction	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hyponatremia	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Headache	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Stroke	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Transient ischemic attacks	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Vocal cord paralysis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Atelectasis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Vascular disorders Hypertension	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Vascular disorders Hypotension	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).

Other adverse events

Measure	Ramucirumab + Atezolizumab n=21 participants at risk * Ramucirumab will be given intravenously over the course of an hour on an outpatient basis on Day 1 of each 21-day cycle at a dose of 10 mg/kg. * Atezolizumab will be given intravenously on an outpatient basis on Day 1 of each 21-day cycle at a dose of 1200 mg.
Blood and lymphatic system disorders Anemia	42.9% 9/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Ear and labyrinth disorders Ear pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Endocrine disorders Hypothyroidism	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Eye disorders Eye pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Abdominal pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Colitis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Constipation	23.8% 5/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Diarrhea	28.6% 6/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Dyspepsia	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Dysphagia	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Mucositis oral	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Nausea	47.6% 10/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Oral pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Stomach pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Gastrointestinal disorders Vomiting	33.3% 7/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
General disorders Chills	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
General disorders Edema limbs	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
General disorders Fatigue	42.9% 9/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
General disorders Non-cardiac chest pain	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
General disorders Pain	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Conjunctivitis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Sinusitis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Skin infection	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Thrush	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Upper respiratory infection	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Urinary tract infection	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Infections and infestations Vulval infection	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Injury, poisoning and procedural complications Vascular access complication	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Alanine aminotransferase increased	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Alkaline phosphatase increased	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Aspartate aminotransferase increased	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Creatinine increased	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Hemoglobin increased	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Lipase increased	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Lymphocyte count decreased	23.8% 5/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Neutrophil count decreased	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Platelet count decreased	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Serum amylase increased	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Thyroid stimulating hormone increased	33.3% 7/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations Weight loss	28.6% 6/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Investigations White blood cell decreased	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Anorexia	42.9% 9/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Dehydration	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hypercalcemia	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hyperglycemia	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hyperkalemia	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hypoalbuminemia	28.6% 6/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hypocalcemia	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hypoglycemia	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Metabolism and nutrition disorders Hyponatremia	28.6% 6/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Flank pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Hernia right groin	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Myalgia	23.8% 5/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Neck pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Pain in extremity	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Pain right groin	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Musculoskeletal and connective tissue disorders Rib pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Cognitive disturbance	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Dizziness	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Dysgeusia	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Dysphasia	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Headache	38.1% 8/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Memory impairment	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Peripheral motor neuropathy	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Peripheral sensory neuropathy	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Right vocal fold paralysis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Nervous system disorders Somnolence	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Psychiatric disorders Anxiety	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Psychiatric disorders Confusion	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Psychiatric disorders Delirium	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Psychiatric disorders Insomnia	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Renal and urinary disorders Hematuria	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Renal and urinary disorders Proteinuria	57.1% 12/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Reproductive system and breast disorders Pelvic pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	14.3% 3/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Cough	38.1% 8/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	19.0% 4/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Epistaxis	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Hemoptysis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Hiccups	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Productive cough	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Respiratory, thoracic and mediastinal disorders Sore throat	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Skin and subcutaneous tissue disorders Alopecia	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Skin and subcutaneous tissue disorders Hyperhidrosis	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	4.8% 1/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Vascular disorders Hypertension	81.0% 17/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).
Vascular disorders Hypotension	9.5% 2/21 • Adverse events were collected from start of treatment through 30 days after the last administration of the study treatment. All-cause mortality was collected from start of treatment until completion of follow-up. The median length of treatment was 92 days (full range 49 days-812 days). The median length of follow-up was 16.3 months (full range 2.3 months-45.6 months).

Additional Information

Daniel Morgensztern, M.D.

Washington University School of Medicine

Phone: 314-747-7948

Email: danielmorgensztern@wustl.edu

Results disclosure agreements

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