Trial Outcomes & Findings for Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer (NCT NCT03272217)
NCT ID: NCT03272217
Last Updated: 2025-01-07
Results Overview
Determine the percentage of overall survival at 1 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
1 years
Results posted on
2025-01-07
Participant Flow
Participant milestones
| Measure |
Arm A - Atezolizumab + Bevacizumab
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atezolizumab With Bevacizumab in Previously Untreated Metastatic/Unresectable Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=16 Participants
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Age, Continuous
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearsDetermine the percentage of overall survival at 1 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.
Outcome measures
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=16 Participants
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Overall Survival (OS) Rate at 1 Year
|
67 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 14 monthsPopulation: Out of 16 subjects, one had no response. Therefore 15 subjects were evaluable for ORR.
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(LD) of target lesions; Progressive Disease (PD): \>= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=15 Participants
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Objective Response Rate (ORR)
|
6.67 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to a maximum of 14 monthsPopulation: Only one subject achieve complete or partial response by RECIST v1.1.
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. DOR is defined as time from measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented by RECIST v1.1.
Outcome measures
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=1 Participants
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Duration of Response (DOR)
|
6.54 Months
|
SECONDARY outcome
Timeframe: Time of treatment start until the criteria for disease progression or death, up to a maximum of 36 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. PFS is defined as time from the date of treatment start until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs
Outcome measures
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=16 Participants
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Progression-Free Survival (PFS)
|
3.25 Months
Interval 2.07 to
Upper limit was not reached due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Adverse events were recorded from time of registration until 30 days after discontinuation of study drug(s), up to maximum of 12 monthsAdverse events were recorded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.
Outcome measures
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=16 Participants
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Number of Participants With Adverse Events
|
16 Participants
|
Adverse Events
Arm A - Atezolizumab + Bevacizumab
Serious events: 8 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=16 participants at risk
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
6.2%
1/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
FEVER
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
KIDNEY INFECTION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
NAUSEA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
PAIN
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
SEPSIS
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.5%
2/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
WOUND INFECTION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
Other adverse events
| Measure |
Arm A - Atezolizumab + Bevacizumab
n=16 participants at risk
Patients will receive atezolizumab 1200 mg (flat dose) IV plus bevacizumab 15 mg/kg IV every 21 days
Atezolizumab: Atezolizumab 1200 mg (flat dose) IV every 21 days
Bevacizumab: Bevacizumab 15 mg/kg IV every 21 days
|
|---|---|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
37.5%
6/16 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
6.2%
1/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - OTHER, SPECIFY
|
12.5%
2/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
RENAL COLIC
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
18.8%
3/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
12.5%
2/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
18.8%
3/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
31.2%
5/16 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY
|
12.5%
2/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
4/16 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
18.8%
3/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
12.5%
2/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
31.2%
5/16 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Psychiatric disorders
AGITATION
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
18.8%
3/16 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
56.2%
9/16 • Number of events 19 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
25.0%
4/16 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
ASCITES
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Immune system disorders
AUTOIMMUNE DISORDER
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
31.2%
5/16 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
BLADDER SPASM
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.2%
1/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Injury, poisoning and procedural complications
BRUISING
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
CHILLS
|
31.2%
5/16 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Psychiatric disorders
CONFUSION
|
18.8%
3/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
25.0%
4/16 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
CREATININE INCREASED
|
43.8%
7/16 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
12.5%
2/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Nervous system disorders
DIZZINESS
|
12.5%
2/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
DUODENAL OBSTRUCTION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Nervous system disorders
DYSGEUSIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
18.8%
3/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
EDEMA LIMBS
|
18.8%
3/16 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Eye disorders
EYE DISORDERS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
FACIAL PAIN
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Injury, poisoning and procedural complications
FALL
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
FATIGUE
|
56.2%
9/16 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
FEVER
|
31.2%
5/16 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
6.2%
1/16 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
FLU LIKE SYMPTOMS
|
6.2%
1/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
31.2%
5/16 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Nervous system disorders
HEADACHE
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
HEMATURIA
|
12.5%
2/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
HEMOGLOBINURIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPERMAGNESEMIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Vascular disorders
HYPERTENSION
|
37.5%
6/16 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
18.8%
3/16 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
6.2%
1/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
12.5%
2/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
25.0%
4/16 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Vascular disorders
HYPOTENSION
|
18.8%
3/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Immune system disorders
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Psychiatric disorders
INSOMNIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
INVESTIGATIONS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Vascular disorders
LYMPHEDEMA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
MUCOSAL INFECTION
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
6.2%
1/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Surgical and medical procedures
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
URINARY RETENTION
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
25.0%
4/16 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
6.2%
1/16 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
12.5%
2/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
6.2%
1/16 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Gastrointestinal disorders
VOMITING
|
25.0%
4/16 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
WEIGHT LOSS
|
18.8%
3/16 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
6.2%
1/16 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 36 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place