Trial Outcomes & Findings for An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study (NCT NCT01588184)
NCT ID: NCT01588184
Last Updated: 2020-11-05
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
95 participants
Primary outcome timeframe
Baseline up to approximately 81 months
Results posted on
2020-11-05
Participant Flow
The number of participants enrolled over the planned recruitment period was open. 95 participants actually enrolled in this study.
Participant milestones
| Measure |
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
41
|
7
|
6
|
16
|
14
|
|
Overall Study
COMPLETED
|
8
|
28
|
5
|
3
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
13
|
2
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
0
|
1
|
0
|
0
|
|
Overall Study
Bevacizumab treatment provision changed
|
0
|
6
|
2
|
0
|
1
|
3
|
|
Overall Study
multiple reasons
|
0
|
3
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study
Baseline characteristics by cohort
| Measure |
Breast Cancer
n=11 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
n=41 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
n=7 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
n=6 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
n=16 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
n=14 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
66.7 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
58.5 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
49.5 years
STANDARD_DEVIATION 10.9 • n=8 Participants
|
56.9 years
STANDARD_DEVIATION 11.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
95 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 81 monthsAn adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Outcome measures
| Measure |
Breast Cancer
n=11 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
n=41 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
n=7 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
n=6 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
n=16 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
n=14 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
90.9 percentage of participants
|
78.0 percentage of participants
|
71.4 percentage of participants
|
100.0 percentage of participants
|
75.0 percentage of participants
|
83.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 81 monthsProgression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Breast Cancer
n=11 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
n=41 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
n=7 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
n=6 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
n=16 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
n=14 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
35.31 months
Standard Deviation 23.809
|
24.39 months
Standard Deviation 19.759
|
17.98 months
Standard Deviation 24.202
|
9.31 months
Standard Deviation 12.046
|
17.14 months
Standard Deviation 14.152
|
11.31 months
Standard Deviation 10.301
|
SECONDARY outcome
Timeframe: Baseline up to approximately 81 monthsOverall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.
Outcome measures
| Measure |
Breast Cancer
n=11 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
n=41 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
n=7 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
n=6 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
n=16 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
n=14 Participants
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
38.82 months
Standard Deviation 24.159
|
27.35 months
Standard Deviation 20.020
|
20.30 months
Standard Deviation 23.761
|
11.98 months
Standard Deviation 10.950
|
18.31 months
Standard Deviation 14.962
|
12.99 months
Standard Deviation 10.795
|
Adverse Events
Breast Cancer
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Ovarian Cancer or Peritoneal Carcinoma
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Colorectal Cancer
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Renal Cell Carcinoma
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Non-Squamous, Non-Small Cell Lung Cancer
Serious events: 5 serious events
Other events: 12 other events
Deaths: 1 deaths
Glioblastoma Multiforme
Serious events: 3 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Breast Cancer
n=11 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
n=41 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
n=7 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
n=6 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
n=16 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
n=14 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
COMPLICATED APPENDICITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
INFECTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
MENINGITIS BACTERIAL
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Vascular disorders
AORTIC STENOSIS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
Other adverse events
| Measure |
Breast Cancer
n=11 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Ovarian Cancer or Peritoneal Carcinoma
n=41 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Colorectal Cancer
n=7 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Renal Cell Carcinoma
n=6 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Non-Squamous, Non-Small Cell Lung Cancer
n=16 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
Glioblastoma Multiforme
n=14 participants at risk
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.2%
2/11 • Number of events 4 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
12.5%
2/16 • Number of events 3 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 3 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
ONYCHOLYSIS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 4 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
12.5%
2/16 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Skin and subcutaneous tissue disorders
SKIN SWELLING
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Vascular disorders
EMBOLISM VENOUS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Vascular disorders
HYPERTENSION
|
18.2%
2/11 • Number of events 3 • Baseline up to approximately 81 months
|
17.1%
7/41 • Number of events 25 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
33.3%
2/6 • Number of events 5 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Vascular disorders
LYMPHOEDEMA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
12.5%
2/16 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
SCIATICA
|
9.1%
1/11 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
SEIZURE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Renal and urinary disorders
PROTEINURIA
|
54.5%
6/11 • Number of events 55 • Baseline up to approximately 81 months
|
48.8%
20/41 • Number of events 100 • Baseline up to approximately 81 months
|
28.6%
2/7 • Number of events 5 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
50.0%
8/16 • Number of events 26 • Baseline up to approximately 81 months
|
35.7%
5/14 • Number of events 15 • Baseline up to approximately 81 months
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
36.4%
4/11 • Number of events 5 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
12.2%
5/41 • Number of events 20 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 7 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 9 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 12 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Blood and lymphatic system disorders
NEUTROPHILIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 10 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Ear and labyrinth disorders
EAR PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Ear and labyrinth disorders
VERTIGO
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Eye disorders
LACRIMATION INCREASED
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Eye disorders
PERIORBITAL DISORDER
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Eye disorders
XEROPHTHALMIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
9.1%
1/11 • Number of events 21 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/11 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
17.1%
7/41 • Number of events 19 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
NAUSEA
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
12.2%
5/41 • Number of events 8 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
18.8%
3/16 • Number of events 7 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Gastrointestinal disorders
VOMITING
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
12.2%
5/41 • Number of events 5 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
General disorders
ASTHENIA
|
36.4%
4/11 • Number of events 5 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 5 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
18.8%
3/16 • Number of events 5 • Baseline up to approximately 81 months
|
35.7%
5/14 • Number of events 6 • Baseline up to approximately 81 months
|
|
General disorders
CHEST PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
General disorders
FATIGUE
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
9.8%
4/41 • Number of events 6 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
General disorders
OEDEMA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
General disorders
OEDEMA PERIPHERAL
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
9.8%
4/41 • Number of events 7 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
12.5%
2/16 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
General disorders
PAIN
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
General disorders
PYREXIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Immune system disorders
SEASONAL ALLERGY
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
BACTERIURIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
BREAST DISCHARGE INFECTED
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
BRONCHITIS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
DIVERTICULITIS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
INFLUENZA
|
9.1%
1/11 • Number of events 2 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
LACRIMAL GLAND ABSCESS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
NAIL INFECTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.1%
1/11 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Infections and infestations
PERIODONTITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
RHINITIS
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Infections and infestations
TOOTH ABSCESS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
TOOTH INFECTION
|
9.1%
1/11 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 4 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/11 • Baseline up to approximately 81 months
|
22.0%
9/41 • Number of events 26 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
9.1%
1/11 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
INCISION SITE PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
9.1%
1/11 • Number of events 3 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Investigations
AMYLASE INCREASED
|
9.1%
1/11 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
18.2%
2/11 • Number of events 3 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
9.1%
1/11 • Number of events 3 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 9 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/11 • Baseline up to approximately 81 months
|
12.2%
5/41 • Number of events 10 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 3 • Baseline up to approximately 81 months
|
|
Investigations
EJECTION FRACTION DECREASED
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
18.2%
2/11 • Number of events 8 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
LIPASE INCREASED
|
9.1%
1/11 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 3 • Baseline up to approximately 81 months
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/11 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
12.5%
2/16 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 4 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
12.5%
2/16 • Number of events 2 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
GOUT
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 15 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
9.8%
4/41 • Number of events 11 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.2%
2/11 • Number of events 2 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
14.3%
2/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
12.2%
5/41 • Number of events 5 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
18.2%
2/11 • Number of events 6 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
36.4%
4/11 • Number of events 7 • Baseline up to approximately 81 months
|
4.9%
2/41 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 2 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
2.4%
1/41 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
APHONIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
COMPLEX REGIONAL PAIN SYNDROME
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/11 • Baseline up to approximately 81 months
|
7.3%
3/41 • Number of events 3 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
DYSAESTHESIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Nervous system disorders
DYSTONIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
FACIAL NEURALGIA
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
HEADACHE
|
27.3%
3/11 • Number of events 5 • Baseline up to approximately 81 months
|
9.8%
4/41 • Number of events 6 • Baseline up to approximately 81 months
|
14.3%
1/7 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
42.9%
6/14 • Number of events 7 • Baseline up to approximately 81 months
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 2 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
16.7%
1/6 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
MOVEMENT DISORDER
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDER
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
0.00%
0/16 • Baseline up to approximately 81 months
|
7.1%
1/14 • Number of events 1 • Baseline up to approximately 81 months
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.00%
0/11 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
|
Nervous system disorders
NEUROTOXICITY
|
9.1%
1/11 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/41 • Baseline up to approximately 81 months
|
0.00%
0/7 • Baseline up to approximately 81 months
|
0.00%
0/6 • Baseline up to approximately 81 months
|
6.2%
1/16 • Number of events 1 • Baseline up to approximately 81 months
|
0.00%
0/14 • Baseline up to approximately 81 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER