Trial Outcomes & Findings for Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer (NCT NCT03600701)
NCT ID: NCT03600701
Last Updated: 2026-08-11
Results Overview
Response is defined as having a complete response (CR) (disappearance of all lesions) or partial response (PR) (\>= 30% decrease in the sum of target lesions) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. A durable response is defined as having a CR or PR response which lasts for at least 6 months.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
Up to 4.6 years
Results posted on
2026-08-11
Participant Flow
Participant milestones
| Measure |
Cohort 1 (KRAS Mutant)
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
28
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1 (KRAS Mutant)
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Rapid decline before starting treatment
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 (KRAS Mutant)
n=25 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=28 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
n=54 Participants
|
64.5 Years
n=54 Participants
|
65 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=54 Participants
|
17 Participants
n=54 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=54 Participants
|
11 Participants
n=54 Participants
|
25 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=54 Participants
|
26 Participants
n=54 Participants
|
48 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=54 Participants
|
23 Participants
n=54 Participants
|
44 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=54 Participants
|
28 participants
n=54 Participants
|
53 participants
n=27 Participants
|
|
Height
|
169.3 Centimeters (cm)
n=54 Participants
|
164.7 Centimeters (cm)
n=54 Participants
|
166.5 Centimeters (cm)
n=27 Participants
|
|
Weight
|
71.4 kilogram (kg)
n=54 Participants
|
63.75 kilogram (kg)
n=54 Participants
|
68.7 kilogram (kg)
n=27 Participants
|
|
BSA
|
1.86 meters squared (m^2)
n=54 Participants
|
1.69 meters squared (m^2)
n=54 Participants
|
1.76 meters squared (m^2)
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 4.6 yearsResponse is defined as having a complete response (CR) (disappearance of all lesions) or partial response (PR) (\>= 30% decrease in the sum of target lesions) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. A durable response is defined as having a CR or PR response which lasts for at least 6 months.
Outcome measures
| Measure |
Cohort 1 (KRAS Mutant)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With a Durable Response
Had a durable response
|
1 Participants
|
2 Participants
|
|
Number of Participants With a Durable Response
Did not have a durable response
|
23 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to 4.6 yearsDisease outcomes are assessed by RECIST version 1.1 criteria and defined as complete response (CR) (disappearance of all lesions), partial response (PR) (\>= 30% decrease in the sum of target lesions), progressive disease (PD) (\>= 20% increase in the sum of target lesions, measurable increase in a non-target lesion, or appearance of a new lesion), or stable disease (SD) (between 20% increase and 30% decrease in the sum of lesions).
Outcome measures
| Measure |
Cohort 1 (KRAS Mutant)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Experiencing a Disease Outcome
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
Number of Participants Experiencing a Disease Outcome
Partial Response (PR)
|
2 Participants
|
2 Participants
|
|
Number of Participants Experiencing a Disease Outcome
Stable Disease (SD)
|
11 Participants
|
8 Participants
|
|
Number of Participants Experiencing a Disease Outcome
Progressive Disease (PD)
|
7 Participants
|
10 Participants
|
|
Number of Participants Experiencing a Disease Outcome
Not evaluated
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 4.6 years (1688 days)Response is complete response (disappearance of all lesions) or partial response (\>= 30% decrease in the sum of target lesions) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Duration is how long that response lasted.
Outcome measures
| Measure |
Cohort 1 (KRAS Mutant)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Duration of Response
|
363.5 Days
Interval 118.0 to 609.0
|
421 Days
Interval 331.0 to 511.0
|
SECONDARY outcome
Timeframe: Up to 4.6 years (1688 days)Progression free survival is from the date of enrollment to the date of the first documented progressive disease (PD) (\>= 20% increase in the sum of target lesions, measurable increase in a non-target lesion, or appearance of a new lesion) as defined by RECIST v1.1 or death due to any cause, whichever occurs first. The date off study was used for participants who did not experience PD or death.
Outcome measures
| Measure |
Cohort 1 (KRAS Mutant)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Duration of Progression Free Survival (PFS)
|
104 Days
Interval 18.0 to 835.0
|
79 Days
Interval 23.0 to 1688.0
|
SECONDARY outcome
Timeframe: Up to 4.6 years (1688 days)Overall survival is from the date enrolled on the study to the date the participant died. The date the participant completed study participant was used for participants who did not die.
Outcome measures
| Measure |
Cohort 1 (KRAS Mutant)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
160 Days
Interval 18.0 to 835.0
|
155 Days
Interval 23.0 to 1688.0
|
SECONDARY outcome
Timeframe: Up to 4.6 yearsAdverse events will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Outcome measures
| Measure |
Cohort 1 (KRAS Mutant)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 Participants
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants Experiencing Grade 3 and 4 Adverse Events
Experienced Grade 4 adverse event
|
0 Participants
|
6 Participants
|
|
Number of Participants Experiencing Grade 3 and 4 Adverse Events
Experienced Grade 3 adverse event
|
15 Participants
|
16 Participants
|
|
Number of Participants Experiencing Grade 3 and 4 Adverse Events
Experienced other grade adverse event
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 90 daysThe analysis of biomarkers will also be descriptive given the limited sample sizes. Categorical data analysis methods such as Chi-square will be used to evaluate the correlation of baseline tumor mutation burden to response to therapy. Regression and correlation will be used for assessing the association between continuous variables such as tumor burden and other markers and patient characteristics such as age.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (KRAS Mutant)
Serious events: 14 serious events
Other events: 24 other events
Deaths: 11 deaths
Cohort 2 (KRAS Wild-type)
Serious events: 14 serious events
Other events: 23 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1 (KRAS Mutant)
n=24 participants at risk
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 participants at risk
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Blood and lymphatic system disorders
Undifferentiated shock
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Colitis
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Death NOS
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Disease progression
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
General disorders
Fever
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
General disorders
Pain
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Infections and infestations
Lung infection
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Infections and infestations
Pneumonia
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Infections and infestations
Sepsis
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Head Injury
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Spinal cord compression
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Syncope
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
2/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/24 • 4.6 years
|
20.8%
5/24 • 4.6 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
Other adverse events
| Measure |
Cohort 1 (KRAS Mutant)
n=24 participants at risk
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
Cohort 2 (KRAS Wild-type)
n=24 participants at risk
Atezolizumab 1680 mg D1 and Cobimetinib 60 mg once daily for 21 days every 28 days until progressive disease or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
3/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Gastrointestinal disorders
Cheilitis
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Constipation
|
8.3%
2/24 • 4.6 years
|
20.8%
5/24 • 4.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
15/24 • 4.6 years
|
66.7%
16/24 • 4.6 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
2/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Heartburn
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Loose Stool
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Gastrointestinal disorders
Nausea
|
45.8%
11/24 • 4.6 years
|
25.0%
6/24 • 4.6 years
|
|
Gastrointestinal disorders
Oral pain
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Gastrointestinal disorders
Stomach pain
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Gastrointestinal disorders
tonsil stones
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
6/24 • 4.6 years
|
45.8%
11/24 • 4.6 years
|
|
General disorders
Ache
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Body ache
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Chills
|
16.7%
4/24 • 4.6 years
|
25.0%
6/24 • 4.6 years
|
|
General disorders
Decreased activity
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Edema face
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
General disorders
Edema limbs
|
8.3%
2/24 • 4.6 years
|
41.7%
10/24 • 4.6 years
|
|
General disorders
Failure to Thrive
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Fatigue
|
37.5%
9/24 • 4.6 years
|
66.7%
16/24 • 4.6 years
|
|
General disorders
Fever
|
20.8%
5/24 • 4.6 years
|
29.2%
7/24 • 4.6 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
General disorders
Gait disturbance
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Hand Foot Syndrome
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
General disorders
Infusion site extravasation
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
General disorders
Lactic acidosis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Malaise
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Pain
|
29.2%
7/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
General disorders
Sleep disorder
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
General disorders
Sleepiness
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
General disorders
Weakness
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Immune system disorders
angiodema
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Infections and infestations
Fungemia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Infections and infestations
Lung infection
|
8.3%
2/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Infections and infestations
Papulopustular rash
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Infections and infestations
Skin infection
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Infections and infestations
Thrush
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
3/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
2/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
4/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
6/24 • 4.6 years
|
33.3%
8/24 • 4.6 years
|
|
Investigations
Blood bilirubin increased
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Investigations
Blood iron decrease
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Cardiac troponin I increased
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Investigations
CPK increased
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Investigations
Creatinine increased
|
4.2%
1/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Investigations
Ejection fraction decreased
|
16.7%
4/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Investigations
elevated blood globulin level
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
hypochloremia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Lipase increased
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Investigations
Lymphocyte count decreased
|
25.0%
6/24 • 4.6 years
|
33.3%
8/24 • 4.6 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Platelet count decreased
|
29.2%
7/24 • 4.6 years
|
29.2%
7/24 • 4.6 years
|
|
Investigations
Serum amylase increased
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Investigations
Weight loss
|
16.7%
4/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Investigations
White blood cell decreased
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
8/24 • 4.6 years
|
33.3%
8/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.2%
7/24 • 4.6 years
|
29.2%
7/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
2/24 • 4.6 years
|
20.8%
5/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
29.2%
7/24 • 4.6 years
|
41.7%
10/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.2%
1/24 • 4.6 years
|
37.5%
9/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
3/24 • 4.6 years
|
41.7%
10/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.2%
1/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.8%
5/24 • 4.6 years
|
29.2%
7/24 • 4.6 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
3/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized joint aches
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
3/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • 4.6 years
|
20.8%
5/24 • 4.6 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Memory impairment
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Nervous system disorders
Somnolence
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Psychiatric disorders
Depression
|
12.5%
3/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Psychiatric disorders
Irritability
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • 4.6 years
|
29.2%
7/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 / mild URI symptoms
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.8%
5/24 • 4.6 years
|
29.2%
7/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
3/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Blistering lips
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
2/24 • 4.6 years
|
12.5%
3/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Easy bruising
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
lower lip skin swelling
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Open sore on back
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
3/24 • 4.6 years
|
25.0%
6/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
29.2%
7/24 • 4.6 years
|
25.0%
6/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.8%
5/24 • 4.6 years
|
25.0%
6/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Scalp Soreness
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Vascular disorders
Flushing
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Eye disorders
Watering eyes
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Endocrine disorders
Acute adrenal crisis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Endocrine disorders
Hyperthyroidism
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Eye disorders
Blurred vision
|
8.3%
2/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Eye disorders
Cataract
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Eye disorders
Dry eye
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Eye disorders
Retinopathy
|
0.00%
0/24 • 4.6 years
|
8.3%
2/24 • 4.6 years
|
|
Eye disorders
subconjunctival hemorrhage
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Eye disorders
Subretinal fluid (ophtho)
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Eye disorders
unable to see color
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Eye disorders
vision change
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Eye disorders
visual disturbance
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Blood and lymphatic system disorders
Anemia
|
54.2%
13/24 • 4.6 years
|
45.8%
11/24 • 4.6 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.2%
1/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Blood and lymphatic system disorders
swollen lymph nodes
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Cardiac disorders
Chest pain - cardiac
|
4.2%
1/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Cardiac disorders
Peripheral edema
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
2/24 • 4.6 years
|
0.00%
0/24 • 4.6 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/24 • 4.6 years
|
16.7%
4/24 • 4.6 years
|
|
Cardiac disorders
Type II demand ischemia
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Ear and labyrinth disorders
Ear fullness
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24 • 4.6 years
|
4.2%
1/24 • 4.6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60