Trial Outcomes & Findings for A Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma (NCT NCT04829383)
NCT ID: NCT04829383
Last Updated: 2026-06-16
Results Overview
Number of participants with grade 3-5 treatment-related adverse event reported by CTCAE v5 term and grade
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Adverse Events have been recorded from the time of consent until 30 days after treatment discontinuation of study drugs or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 10 months
Results posted on
2026-06-16
Participant Flow
Participant milestones
| Measure |
Atezolizumab Plus Bevacizumab
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Atezolizumab Plus Bevacizumab
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
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|---|---|
|
Overall Study
Death Related to Progressive Disease
|
3
|
|
Overall Study
Subject admitted to hospital with hypotension and GI bleed, expired during hospitalization course
|
1
|
|
Overall Study
Patient had no plans for returning to IU and was admitted to Hospice Care
|
1
|
Baseline Characteristics
A Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
Atezolizumab Plus Bevacizumab
n=6 Participants
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=20 Participants
|
|
ECOG
1
|
5 Participants
n=20 Participants
|
|
ECOG
0
|
0 Participants
n=20 Participants
|
|
ECOG
Vital Sign Not Collected
|
1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Adverse Events have been recorded from the time of consent until 30 days after treatment discontinuation of study drugs or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 10 monthsPopulation: In accordance with the Statistical Analysis Plan, the analysis population for Adverse Events was defined as all patients receiving at least one dose of study treatment regardless of the dosage.
Number of participants with grade 3-5 treatment-related adverse event reported by CTCAE v5 term and grade
Outcome measures
| Measure |
Atezolizumab Plus Bevacizumab
n=6 Participants
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
|
|---|---|
|
Grade 3-5 Adverse Events
ALANINE AMINOTRANSFERASE INCREASED
|
1 Participants
|
|
Grade 3-5 Adverse Events
ASPARTATE AMINOTRANSFERASE INCREASED
|
1 Participants
|
|
Grade 3-5 Adverse Events
GASTRIC HEMORRHAGE
|
1 Participants
|
|
Grade 3-5 Adverse Events
ANEMIA
|
1 Participants
|
|
Grade 3-5 Adverse Events
FATIGUE
|
1 Participants
|
|
Grade 3-5 Adverse Events
PAIN IN EXTREMITY
|
1 Participants
|
|
Grade 3-5 Adverse Events
ACUTE KIDNEY INJURY
|
1 Participants
|
|
Grade 3-5 Adverse Events
ESOPHAGEAL VARICES HEMORRHAGE
|
1 Participants
|
|
Grade 3-5 Adverse Events
SEPSIS
|
1 Participants
|
|
Grade 3-5 Adverse Events
UPPER GASTROINTESTINAL HEMORRHAGE
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 11 monthsPopulation: None of the subjects had any documented CR or PR according to RECIST v1.1
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Atezolizumab Plus Bevacizumab
n=6 Participants
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
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|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
0 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 11 months.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. DCR defined as the proportion of patients who have a CR, PR or SD for at least 16 weeks according to RECIST v1.1
Outcome measures
| Measure |
Atezolizumab Plus Bevacizumab
n=6 Participants
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
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|---|---|
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Disease Control Rate (DCR)
Complete Response
|
0 Participants
|
|
Disease Control Rate (DCR)
Partial Response
|
0 Participants
|
|
Disease Control Rate (DCR)
Stable Disease
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 11 monthsPopulation: No subjects achieved an objective response according to RECIST v1.1 criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Duration of response (DOR) defined as the the length of time from the first occurrence of an objective response to disease progression or death from any cause according to RECIST v1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to a maximum of 11 months.Population: No formal analysis of Overall survival (OS) was conducted for this study. Therefore, OS data for each participant is reported separately per row. Of the 6 participants, 4 died and 2 (Subjects 1003 and 1006) were censored at their last known alive date.
Overall survival (OS) defined as the time from start of treatment to death from any cause. Participants who were alive at the time of analysis were censored at their last known date alive.
Outcome measures
| Measure |
Atezolizumab Plus Bevacizumab
n=6 Participants
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
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|---|---|
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Overall Survival (OS)
Subject 1001
|
10.58 months
|
|
Overall Survival (OS)
Subject 1002
|
8.18 months
|
|
Overall Survival (OS)
Subject 1003
|
3.02 months
|
|
Overall Survival (OS)
Subject 1004
|
1.81 months
|
|
Overall Survival (OS)
Subject 1005
|
9.82 months
|
|
Overall Survival (OS)
Subject 1006
|
10.35 months
|
SECONDARY outcome
Timeframe: Up to a maximum of 11 months.Population: No formal analysis of progression-free survival (PFS) was conducted for this study. Therefore, PFS data for each participant is reported separately per row.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Progression-free survival (PFS) defined as the time from start of treatment to disease progression or death from any cause according to RECIST v1.1
Outcome measures
| Measure |
Atezolizumab Plus Bevacizumab
n=6 Participants
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
|
|---|---|
|
Progression-free Survival (PFS)
Subject 1001
|
10.58 months
|
|
Progression-free Survival (PFS)
Subject 1002
|
4.6 months
|
|
Progression-free Survival (PFS)
Subject 1003
|
2.07 months
|
|
Progression-free Survival (PFS)
Subject 1004
|
1.81 months
|
|
Progression-free Survival (PFS)
Subject 1005
|
7.52 months
|
|
Progression-free Survival (PFS)
Subject 1006
|
10.25 months
|
Adverse Events
Atezolizumab Plus Bevacizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Atezolizumab Plus Bevacizumab
n=6 participants at risk
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
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|---|---|
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RENAL AND URINARY DISORDERS
ACUTE KIDNEY INJURY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANEMIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
ESOPHAGEAL VARICES HEMORRHAGE
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
GENERALIZED MUSCLE WEAKNESS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INFECTIONS AND INFESTATIONS
SEPSIS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
UPPER GASTROINTESTINAL HEMORRHAGE
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
Other adverse events
| Measure |
Atezolizumab Plus Bevacizumab
n=6 participants at risk
Eligible consented patients will receive atezolizumab 1,200 mg IV and bevacizumab 15 mg/kg IV every 3 weeks (on day 1 of each 21-day cycle). Treatment will continue until disease progression or development of unacceptable toxicity.
|
|---|---|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
COUGH
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
DIARRHEA
|
50.0%
3/6 • Number of events 5 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
EYE DISORDERS
DRY EYE
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 4 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INVESTIGATIONS
ALANINE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INVESTIGATIONS
ALKALINE PHOSPHATASE INCREASED
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
ALLERGIC RHINITIS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
ANEMIA
|
50.0%
3/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
METABOLISM AND NUTRITION DISORDERS
ANOREXIA
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
PSYCHIATRIC DISORDERS
ANXIETY
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
ARTHRITIS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
ASCITES
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INVESTIGATIONS
ASPARTATE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 5 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
BACK PAIN
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INVESTIGATIONS
BLOOD BILIRUBIN INCREASED
|
50.0%
3/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
PSYCHIATRIC DISORDERS
CONFUSION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
CONSTIPATION
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
DRY MOUTH
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
NERVOUS SYSTEM DISORDERS
DYSGEUSIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
DYSPNEA
|
16.7%
1/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
EDEMA LIMBS
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
EPISTAXIS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
FALL
|
33.3%
2/6 • Number of events 5 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
FATIGUE
|
83.3%
5/6 • Number of events 6 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
GASTRIC HEMORRHAGE
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
GASTROESOPHAGEAL REFLUX DISEASE
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
GENERALIZED MUSCLE WEAKNESS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
PSYCHIATRIC DISORDERS
HALLUCINATIONS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
HOARSENESS
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERGLYCEMIA
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPERLIPIDEMIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOALBUMINEMIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPOCALCEMIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
METABOLISM AND NUTRITION DISORDERS
HYPONATREMIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
ENDOCRINE DISORDERS
HYPOTHYROIDISM
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
PSYCHIATRIC DISORDERS
INSOMNIA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
MUCOSITIS ORAL
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
NAUSEA
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
PAIN IN EXTREMITY
|
33.3%
2/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
NERVOUS SYSTEM DISORDERS
PERIPHERAL SENSORY NEUROPATHY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INVESTIGATIONS
PLATELET COUNT DECREASED
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
PLEURAL EFFUSION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
HEPATOBILIARY DISORDERS
PORTAL HYPERTENSION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
POSTNASAL DRIP
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
NERVOUS SYSTEM DISORDERS
RADICULITIS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
SINUS DISORDER
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
SINUS PAIN
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
SKIN ATROPHY
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
SLEEP APNEA
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
SORE THROAT
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INFECTIONS AND INFESTATIONS
THRUSH
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
EAR AND LABYRINTH DISORDERS
TINNITUS
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INFECTIONS AND INFESTATIONS
UPPER RESPIRATORY INFECTION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
INFECTIONS AND INFESTATIONS
URINARY TRACT INFECTION
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
|
GASTROINTESTINAL DISORDERS
VOMITING
|
50.0%
3/6 • Number of events 3 • All-Cause Mortality was assessed up to 11 months, and Serious and Other (Not Including Serious) adverse events were assessed up to 10 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place