Trial Outcomes & Findings for Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy (NCT NCT04068896)
NCT ID: NCT04068896
Last Updated: 2025-05-29
Results Overview
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
89 participants
Primary outcome timeframe
From enrollment to end of treatment up to 24 months
Results posted on
2025-05-29
Participant Flow
89 patients were enrolled (signed consent), however only 87 patients received at least 1 dose of study treatment. The participant flow contains information from these 87 treated patients, that are also considered the Safety Analysis set for CSR and study results
Participant milestones
| Measure |
Part 1 NGM120 30 mg
NGM120 30 mg Subcutaneous Injection
|
Part 1 NGM120 100 mg
NGM120 100 mg Subcutaneous Injection
|
Part 2 NGM120 30 mg
NGM120 30 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100 mg
NGM120 100 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
Placebo subcutaneous injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100 mg
NGM120 100 mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
31
|
20
|
6
|
|
Overall Study
COMPLETED
|
0
|
1
|
2
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
8
|
27
|
20
|
6
|
Reasons for withdrawal
| Measure |
Part 1 NGM120 30 mg
NGM120 30 mg Subcutaneous Injection
|
Part 1 NGM120 100 mg
NGM120 100 mg Subcutaneous Injection
|
Part 2 NGM120 30 mg
NGM120 30 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100 mg
NGM120 100 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
Placebo subcutaneous injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100 mg
NGM120 100 mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
3
|
1
|
3
|
19
|
17
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
progressive disease
|
3
|
5
|
3
|
2
|
1
|
2
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
1
|
2
|
1
|
4
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
2
|
1
|
0
|
|
Overall Study
Symptomatic deterioration
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study of NGM120 in Subjects With Advanced Solid Tumors, Pancreatic Cancer, and Prostate Cancer Using Combination Therapy
Baseline characteristics by cohort
| Measure |
Part 1 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection
|
Part 1 NGM120 100mg
n=10 Participants
NGM120 100 mg Subcutaneous Injection
|
Part 2 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100mg
n=31 Participants
NGM120 100 mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
n=20 Participants
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle)
|
Part 3 NGM120 100mg
n=6 Participants
NGM120 100 mg Subcutaneous Injection
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
73 Participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 9.08 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 12.21 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 9.06 • n=4 Participants
|
69.9 years
STANDARD_DEVIATION 8.10 • n=21 Participants
|
69.0 years
STANDARD_DEVIATION 11.92 • n=8 Participants
|
67.2 years
STANDARD_DEVIATION 8.78 • n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 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
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
53 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
BMI
|
24.93 kg/m2
STANDARD_DEVIATION 5.759 • n=5 Participants
|
26.46 kg/m2
STANDARD_DEVIATION 4.636 • n=7 Participants
|
26.53 kg/m2
STANDARD_DEVIATION 9.694 • n=5 Participants
|
25.72 kg/m2
STANDARD_DEVIATION 5.119 • n=4 Participants
|
25.04 kg/m2
STANDARD_DEVIATION 5.113 • n=21 Participants
|
31.20 kg/m2
STANDARD_DEVIATION 5.852 • n=8 Participants
|
26.03 kg/m2
STANDARD_DEVIATION 5.89 • n=8 Participants
|
|
Metastatic Disease
Yes
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
83 Participants
n=8 Participants
|
|
Metastatic Disease
No
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Sites of Metastases
Bone
|
3 count of metastatic sites
n=5 Participants
|
6 count of metastatic sites
n=7 Participants
|
1 count of metastatic sites
n=5 Participants
|
1 count of metastatic sites
n=4 Participants
|
0 count of metastatic sites
n=21 Participants
|
5 count of metastatic sites
n=8 Participants
|
16 count of metastatic sites
n=8 Participants
|
|
Sites of Metastases
Liver
|
5 count of metastatic sites
n=5 Participants
|
4 count of metastatic sites
n=7 Participants
|
5 count of metastatic sites
n=5 Participants
|
17 count of metastatic sites
n=4 Participants
|
16 count of metastatic sites
n=21 Participants
|
0 count of metastatic sites
n=8 Participants
|
47 count of metastatic sites
n=8 Participants
|
|
Sites of Metastases
Lung
|
2 count of metastatic sites
n=5 Participants
|
4 count of metastatic sites
n=7 Participants
|
4 count of metastatic sites
n=5 Participants
|
10 count of metastatic sites
n=4 Participants
|
5 count of metastatic sites
n=21 Participants
|
1 count of metastatic sites
n=8 Participants
|
26 count of metastatic sites
n=8 Participants
|
|
Sites of Metastases
Peritoneum
|
2 count of metastatic sites
n=5 Participants
|
0 count of metastatic sites
n=7 Participants
|
2 count of metastatic sites
n=5 Participants
|
2 count of metastatic sites
n=4 Participants
|
0 count of metastatic sites
n=21 Participants
|
0 count of metastatic sites
n=8 Participants
|
6 count of metastatic sites
n=8 Participants
|
|
Sites of Metastases
Other
|
2 count of metastatic sites
n=5 Participants
|
2 count of metastatic sites
n=7 Participants
|
1 count of metastatic sites
n=5 Participants
|
5 count of metastatic sites
n=4 Participants
|
3 count of metastatic sites
n=21 Participants
|
2 count of metastatic sites
n=8 Participants
|
15 count of metastatic sites
n=8 Participants
|
|
Time from Initial cancer diagnosis
|
40.775 Months
STANDARD_DEVIATION 21.0265 • n=5 Participants
|
61.841 Months
STANDARD_DEVIATION 67.6111 • n=7 Participants
|
6.328 Months
STANDARD_DEVIATION 12.9190 • n=5 Participants
|
4.769 Months
STANDARD_DEVIATION 7.4036 • n=4 Participants
|
4.350 Months
STANDARD_DEVIATION 6.1938 • n=21 Participants
|
140.167 Months
STANDARD_DEVIATION 69.4910 • n=8 Participants
|
24.86 Months
STANDARD_DEVIATION 47.45 • n=8 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of treatment up to 24 monthsPopulation: Safety analysis set
Number of Participants with NGM120/Placebo-Related Treatment Emergent Adverse Events
Outcome measures
| Measure |
Part 1 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection
|
Part 1 NGM120 100mg
n=10 Participants
NGM120 100mg Subcutaneous Injection
|
Part 2 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100mg
n=31 Participants
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
n=20 Participants
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100mg
n=6 Participants
NGM120 100mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
To Determine the Safety and Tolerability of NGM120 in Subjects
|
1 Participants
|
6 Participants
|
6 Participants
|
17 Participants
|
12 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of treatment up to 24 monthsPopulation: Safety analysis set
Discontinuation of investigational product due to toxicity
Outcome measures
| Measure |
Part 1 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection
|
Part 1 NGM120 100mg
n=10 Participants
NGM120 100mg Subcutaneous Injection
|
Part 2 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100mg
n=31 Participants
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
n=20 Participants
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100mg
n=6 Participants
NGM120 100mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
To Determine the Safety and Tolerability of NGM120
|
2 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of treatment up to 24 monthsPopulation: Safety analysis set
Local injection-site symptom assessment as evidenced by incidence of injection-site reactions
Outcome measures
| Measure |
Part 1 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection
|
Part 1 NGM120 100mg
n=10 Participants
NGM120 100mg Subcutaneous Injection
|
Part 2 NGM120 30mg
n=10 Participants
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100mg
n=31 Participants
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
n=20 Participants
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100mg
n=6 Participants
NGM120 100mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
To Determine the Safety and Tolerability of NGM120
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1 NGM120 30mg
Serious events: 5 serious events
Other events: 10 other events
Deaths: 3 deaths
Part 1 NGM120 100mg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Part 2 NGM120 30mg
Serious events: 5 serious events
Other events: 10 other events
Deaths: 3 deaths
Part 2 NGM120 100mg
Serious events: 26 serious events
Other events: 31 other events
Deaths: 19 deaths
Part 2 Placebo
Serious events: 10 serious events
Other events: 20 other events
Deaths: 17 deaths
Part 3 NGM120 100mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 NGM120 30mg
n=10 participants at risk
NGM120 30mg Subcutaneous Injection
|
Part 1 NGM120 100mg
n=10 participants at risk
NGM120 100mg Subcutaneous Injection
|
Part 2 NGM120 30mg
n=10 participants at risk
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100mg
n=31 participants at risk
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
n=20 participants at risk
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100mg
n=6 participants at risk
NGM120 100mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
20.0%
2/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Prostatic Abscess
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Septic shock
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Product Issues
Device occlusion
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
Other adverse events
| Measure |
Part 1 NGM120 30mg
n=10 participants at risk
NGM120 30mg Subcutaneous Injection
|
Part 1 NGM120 100mg
n=10 participants at risk
NGM120 100mg Subcutaneous Injection
|
Part 2 NGM120 30mg
n=10 participants at risk
NGM120 30mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 NGM120 100mg
n=31 participants at risk
NGM120 100mg Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 2 Placebo
n=20 participants at risk
Placebo Subcutaneous Injection together with gemcitabine (1000 mg/m2 weekly for first 3 weeks of the 4-week cycle) and Abraxane (125 mg/m2 weekly for first 3 weeks of the 4-week cycle).
|
Part 3 NGM120 100mg
n=6 participants at risk
NGM120 100mg Subcutaneous Injection
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Paronychia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
3/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
50.0%
5/10 • 3 years, 8 months.
|
51.6%
16/31 • 3 years, 8 months.
|
55.0%
11/20 • 3 years, 8 months.
|
33.3%
2/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
22.6%
7/31 • 3 years, 8 months.
|
30.0%
6/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
29.0%
9/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
70.0%
7/10 • 3 years, 8 months.
|
48.4%
15/31 • 3 years, 8 months.
|
40.0%
8/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
70.0%
7/10 • 3 years, 8 months.
|
41.9%
13/31 • 3 years, 8 months.
|
40.0%
8/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Asthenia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Chills
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Generalised oedema
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
General disorders
Injection site erythema
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Injection site laceration
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Malaise
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
70.0%
7/10 • 3 years, 8 months.
|
41.9%
13/31 • 3 years, 8 months.
|
35.0%
7/20 • 3 years, 8 months.
|
33.3%
2/6 • 3 years, 8 months.
|
|
General disorders
Pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
60.0%
6/10 • 3 years, 8 months.
|
45.2%
14/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
General disorders
Fatigue
|
40.0%
4/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
70.0%
7/10 • 3 years, 8 months.
|
71.0%
22/31 • 3 years, 8 months.
|
55.0%
11/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Candida infection
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Amylase increased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Gamma-glutamyltransferase increased
|
40.0%
4/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Hepatic enzyme increased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Lipase increased
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
50.0%
5/10 • 3 years, 8 months.
|
41.9%
13/31 • 3 years, 8 months.
|
45.0%
9/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
32.3%
10/31 • 3 years, 8 months.
|
45.0%
9/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Transaminases increased
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Weight decreased
|
20.0%
2/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
50.0%
5/10 • 3 years, 8 months.
|
32.3%
10/31 • 3 years, 8 months.
|
30.0%
6/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
Weight increased
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
50.0%
5/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
50.0%
5/10 • 3 years, 8 months.
|
29.0%
9/31 • 3 years, 8 months.
|
30.0%
6/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Psychiatric disorders
Insomnia
|
30.0%
3/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
38.7%
12/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
80.0%
8/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
30.0%
6/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
50.0%
5/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
35.0%
7/20 • 3 years, 8 months.
|
33.3%
2/6 • 3 years, 8 months.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Vena cava thrombosis
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
16.1%
5/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
30.0%
3/10 • 3 years, 8 months.
|
32.3%
10/31 • 3 years, 8 months.
|
20.0%
4/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
2/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
15.0%
3/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
19.4%
6/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
40.0%
4/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
2/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
16.7%
1/6 • 3 years, 8 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
9.7%
3/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
10.0%
2/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
20.0%
2/10 • 3 years, 8 months.
|
12.9%
4/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
0.00%
0/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
6.5%
2/31 • 3 years, 8 months.
|
5.0%
1/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • 3 years, 8 months.
|
0.00%
0/10 • 3 years, 8 months.
|
10.0%
1/10 • 3 years, 8 months.
|
3.2%
1/31 • 3 years, 8 months.
|
0.00%
0/20 • 3 years, 8 months.
|
0.00%
0/6 • 3 years, 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place