Trial Outcomes & Findings for Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer (NCT NCT02873195)
NCT ID: NCT02873195
Last Updated: 2024-08-23
Results Overview
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The primary comparisons will be superiority of the active treatment for PFS of atezolizumab versus placebo. PFS will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.10 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
133 participants
Primary outcome timeframe
From randomization to first documentation of disease progression by RECIST v1.1, or death from any cause, assessed up to 20 months
Results posted on
2024-08-23
Participant Flow
Participant milestones
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
46
|
|
Overall Study
Never Began Treatment (Cancel)
|
1
|
0
|
|
Overall Study
COMPLETED
|
82
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Ineligible
|
5
|
0
|
Baseline Characteristics
Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=82 Participants
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 Participants
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
56 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
39 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
43 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to first documentation of disease progression by RECIST v1.1, or death from any cause, assessed up to 20 monthsPopulation: Modified Intent-to-treat (ITT) population
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The primary comparisons will be superiority of the active treatment for PFS of atezolizumab versus placebo. PFS will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.10 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Outcome measures
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=82 Participants
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 Participants
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.37 months
Interval 4.07 to 6.41
|
3.32 months
Interval 2.14 to 6.21
|
SECONDARY outcome
Timeframe: From randomization to death due to any cause, assessed up to 20 monthsPopulation: Modified Intent-to-treat (ITT) population
The distribution of survival time will be estimated using the method of Kaplan-Meier. OS will be compared between treatment arms using the unstratified log-rank test. OS medians, survival rates and HR will be estimated along with 95% confidence intervals.
Outcome measures
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=82 Participants
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 Participants
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
10.55 months
Interval 8.21 to
The 95% confidence interval upper limit was not reached (below the level of detection).
|
10.61 months
Interval 8.8 to
The 95% confidence interval upper limit was not reached (below the level of detection).
|
SECONDARY outcome
Timeframe: Up to 20 monthsPopulation: Modified Intent-to-treat (ITT) population
The objective response rate is defined as the percentage of participants who achieve a partial response or compete response as assessed (partial response \[PR\] or complete response \[CR\] per RECIST v1.1) during treatment with study therapy. Rates of response will be compared across arms using a fisher's exact test for proportion. Point estimates will be generated for objective response rates within each arm along with 95% binomial confidence intervals. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites
Outcome measures
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=82 Participants
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 Participants
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate
|
8.54 percentage of participants
Interval 3.5 to 16.8
|
4.35 percentage of participants
Interval 0.53 to 14.84
|
SECONDARY outcome
Timeframe: Up to 20 monthsPopulation: Participants who started treatment and are evaluable for adverse events are included in this analysis.
The number of participants who experienced at least one grade 3 or higher adverse event deemed at least possibly related to treatment (toxicity) is reported below. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading.
Outcome measures
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=81 Participants
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 Participants
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
The Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment (Toxicity)
|
27 Participants
|
11 Participants
|
Adverse Events
Atezolizumab, Bevacizumab, Capecitabine
Serious events: 36 serious events
Other events: 77 other events
Deaths: 45 deaths
Placebo, Bevacizumab, Capecitabine
Serious events: 12 serious events
Other events: 42 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=81 participants at risk
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 participants at risk
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Cardiac disorders
Myocarditis
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Eye disorders
Blurred vision
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
3/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Colitis
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Death NOS
|
8.6%
7/81 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Fatigue
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Fever
|
4.9%
4/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Flu like symptoms
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Multi-organ failure
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Sudden death NOS
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Lung infection
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Papulopustular rash
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Peripheral nerve infection
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Sepsis
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Upper respiratory infection
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Platelet count decreased
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Dysarthria
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Facial muscle weakness
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Psychiatric disorders
Confusion
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Hematuria
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Hypertension
|
7.4%
6/81 • Number of events 11 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Thromboembolic event
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
Other adverse events
| Measure |
Atezolizumab, Bevacizumab, Capecitabine
n=81 participants at risk
Patients receive 1200 mg atezolizumab IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Placebo, Bevacizumab, Capecitabine
n=46 participants at risk
Patients receive 1200 mg placebo IV over 30-60 minutes on day 1, 7.5 mg/kg bevacizumab IV over 30-90 minutes on day 1, and 850 or 1000 mg/m\^2 capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Eye disorders
Watering eyes
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
3/81 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Blood and lymphatic system disorders
Anemia
|
14.8%
12/81 • Number of events 36 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
15.2%
7/46 • Number of events 12 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Eye disorders
Blurred vision
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Eye disorders
Eye disorders - Other, specify
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.9%
21/81 • Number of events 49 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
15.2%
7/46 • Number of events 18 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Ascites
|
3.7%
3/81 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Constipation
|
21.0%
17/81 • Number of events 31 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
10.9%
5/46 • Number of events 5 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Dental caries
|
1.2%
1/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Diarrhea
|
58.0%
47/81 • Number of events 117 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
30.4%
14/46 • Number of events 45 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Dry mouth
|
4.9%
4/81 • Number of events 15 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 5 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.7%
3/81 • Number of events 11 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.5%
2/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Mucositis oral
|
17.3%
14/81 • Number of events 28 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Nausea
|
54.3%
44/81 • Number of events 123 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
43.5%
20/46 • Number of events 42 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Oral pain
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Stomach pain
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Toothache
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
26/81 • Number of events 41 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
28.3%
13/46 • Number of events 24 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Chills
|
3.7%
3/81 • Number of events 5 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Edema limbs
|
8.6%
7/81 • Number of events 21 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 14 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Fatigue
|
88.9%
72/81 • Number of events 369 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
73.9%
34/46 • Number of events 161 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Fever
|
9.9%
8/81 • Number of events 11 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
6.5%
3/46 • Number of events 6 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
General disorders
Pain
|
6.2%
5/81 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Immune system disorders
Allergic reaction
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Rhinitis infective
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Skin infection
|
2.5%
2/81 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Upper respiratory infection
|
2.5%
2/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
5/81 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Infections and infestations
Vaginal infection
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
4/81 • Number of events 5 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Alkaline phosphatase increased
|
3.7%
3/81 • Number of events 6 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
10.9%
5/46 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Aspartate aminotransferase increased
|
4.9%
4/81 • Number of events 6 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Blood bilirubin increased
|
14.8%
12/81 • Number of events 24 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
15.2%
7/46 • Number of events 14 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
CPK increased
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 5 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Creatinine increased
|
7.4%
6/81 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
INR increased
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
5/81 • Number of events 33 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Lymphocyte count increased
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Neutrophil count decreased
|
1.2%
1/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Platelet count decreased
|
13.6%
11/81 • Number of events 38 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
15.2%
7/46 • Number of events 19 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Serum amylase increased
|
2.5%
2/81 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
Weight loss
|
3.7%
3/81 • Number of events 12 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Investigations
White blood cell decreased
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.5%
19/81 • Number of events 33 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
19.6%
9/46 • Number of events 14 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.2%
1/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
13.0%
6/46 • Number of events 15 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
3/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.6%
7/81 • Number of events 16 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
3/81 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.4%
6/81 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
3/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
6/81 • Number of events 10 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
6.5%
3/46 • Number of events 12 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/81 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
6/81 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
13.0%
6/46 • Number of events 10 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
5/81 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 6 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.5%
2/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
5/81 • Number of events 11 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
6.5%
3/46 • Number of events 5 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Cognitive disturbance
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Dizziness
|
4.9%
4/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Headache
|
4.9%
4/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.6%
11/81 • Number of events 69 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
21.7%
10/46 • Number of events 28 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Psychiatric disorders
Depression
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Psychiatric disorders
Insomnia
|
6.2%
5/81 • Number of events 6 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 9 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
2/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.2%
1/81 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Proteinuria
|
12.3%
10/81 • Number of events 24 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
17.4%
8/46 • Number of events 21 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Renal and urinary disorders
Urinary tract pain
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Reproductive system and breast disorders
Vaginal pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.9%
4/81 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.3%
10/81 • Number of events 21 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 11 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
6/81 • Number of events 11 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
6.5%
3/46 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
2/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.2%
1/81 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 7 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 6 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
2/81 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
6.5%
3/46 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.6%
11/81 • Number of events 21 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
8.7%
4/46 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
40.7%
33/81 • Number of events 89 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
34.8%
16/46 • Number of events 57 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
2/81 • Number of events 3 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 4 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
11.1%
9/81 • Number of events 22 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 13 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.7%
3/81 • Number of events 13 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Hematoma
|
1.2%
1/81 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Hypertension
|
24.7%
20/81 • Number of events 66 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
30.4%
14/46 • Number of events 59 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Hypotension
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
4.3%
2/46 • Number of events 2 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Thromboembolic event
|
3.7%
3/81 • Number of events 8 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
0.00%
0/46 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/81 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
2.2%
1/46 • Number of events 1 • Up to 20 months
Participants who started treatment and were assessed for adverse events are summarized below.
|
Additional Information
Niharika Bansal Mettu, M.D.
Duke University Medical Center
Phone: 919-681-2954
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place