Trial Outcomes & Findings for A Study of IMC-CS4 in Subjects With Advanced Solid Tumors (NCT NCT01346358)
NCT ID: NCT01346358
Last Updated: 2024-09-19
Results Overview
Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Results posted on
2024-09-19
Participant Flow
Completers included participants who died from any cause or disease progression and participants who were alive and on study (either on study treatment or in long term follow-up) at study conclusion.
Participant milestones
| Measure |
Cohort 1 (2.5 Milligram Per Kilogram (mg/kg) QW)
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly (QW) by intravenous infusion.
|
Cohort 2 (0.3 mg/kg QW)
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 3 (0.6 mg/kg QW)
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 4 (1.25 mg/kg Q2W)
Participants received 1.25 mg/kg of IMC-CS4 every two weeks (Q2W) by intravenous infusion.
|
Cohort 4 Expanded (1.25 mg/kg Q2W)
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 5 (1.25 mg/kg QW)
Participants received 1.25 mg/kg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
3
|
6
|
5
|
5
|
3
|
11
|
9
|
|
Overall Study
COMPLETED
|
4
|
3
|
2
|
5
|
4
|
3
|
2
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
1
|
1
|
2
|
1
|
4
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1 (2.5 Milligram Per Kilogram (mg/kg) QW)
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly (QW) by intravenous infusion.
|
Cohort 2 (0.3 mg/kg QW)
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 3 (0.6 mg/kg QW)
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 4 (1.25 mg/kg Q2W)
Participants received 1.25 mg/kg of IMC-CS4 every two weeks (Q2W) by intravenous infusion.
|
Cohort 4 Expanded (1.25 mg/kg Q2W)
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 5 (1.25 mg/kg QW)
Participants received 1.25 mg/kg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Non-Compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of IMC-CS4 in Subjects With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1 (2.5 Milligram Per Kilogram (mg/kg) QW)
n=6 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 2 (0.3 mg/kg QW)
n=4 Participants
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 3 (0.6 mg/kg QW)
n=3 Participants
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 4 (1.25 mg/kg Q2W)
n=6 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
Cohort 4 Expanded (1.25 mg/kg Q2W)
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 5 (1.25 mg/kg QW)
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a (100 mg QW)
n=3 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
n=11 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
n=9 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
52 Participants
n=42 Participants
|
|
Age, Continuous
|
58.3 Years
STANDARD_DEVIATION 6.22 • n=5 Participants
|
63.3 Years
STANDARD_DEVIATION 1.71 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 4.58 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 12.57 • n=4 Participants
|
60.8 Years
STANDARD_DEVIATION 13.99 • n=21 Participants
|
51.6 Years
STANDARD_DEVIATION 12.62 • n=8 Participants
|
54.0 Years
STANDARD_DEVIATION 10.15 • n=8 Participants
|
55.5 Years
STANDARD_DEVIATION 12.26 • n=24 Participants
|
59.1 Years
STANDARD_DEVIATION 8.58 • n=42 Participants
|
58.6 Years
STANDARD_DEVIATION 10.43 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
38 Participants
n=42 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
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Cmax.
Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=6 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
n=4 Participants
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
n=10 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
n=14 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
n=8 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Cycle 1 Day 1
|
69.2 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 13
|
6.83 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 32
|
13.5 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 33
|
26.0 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 14
|
31.2 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 24
|
32.2 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 25
|
42.9 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
|
Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
30.0 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Cycle 1 Day 22
|
92.7 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
42.8 Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation 59
|
NA Microgram/milliliters (µg/mL)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants.
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Cmin.
Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=6 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
n=2 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
n=9 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
n=8 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Cycle 1 Day 1
|
14.4 µg/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
NA µg/mL
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants.
|
3.32 µg/mL
Geometric Coefficient of Variation 11
|
3.77 µg/mL
Geometric Coefficient of Variation 79
|
5.15 µg/mL
Geometric Coefficient of Variation 81
|
—
|
—
|
|
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
3.35 µg/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Cycle 1 Day 22
|
29.9 µg/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
21.9 µg/mL
Geometric Coefficient of Variation 86
|
NA µg/mL
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants.
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data for AUC.
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=6 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
n=10 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
n=14 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
n=8 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Cycle 1 Day 1
|
5020 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 18
|
256 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 14
|
492 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 23
|
1810 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 21
|
1550 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 50
|
1780 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 43
|
2810 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
|
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
1700 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Cycle 1 Day 22
|
11300 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
4430 Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation 80
|
NA Hours* microgram per mL (h*µg/mL)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants.
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Vss.
Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=6 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
n=10 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
n=14 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
n=8 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Cycle 1 Day 1
|
4.80 Liters (L)
Geometric Coefficient of Variation 40
|
4.61 Liters (L)
Geometric Coefficient of Variation 4
|
3.21 Liters (L)
Geometric Coefficient of Variation 12
|
4.85 Liters (L)
Geometric Coefficient of Variation 8
|
3.59 Liters (L)
Geometric Coefficient of Variation 24
|
4.12 Liters (L)
Geometric Coefficient of Variation 14
|
4.87 Liters (L)
Geometric Coefficient of Variation 26
|
—
|
—
|
|
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
3.47 Liters (L)
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Cycle 1 Day 22
|
6.11 Liters (L)
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
4.84 Liters (L)
Geometric Coefficient of Variation 60
|
NA Liters (L)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants.
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1Population: All enrolled participants who received at least one dose of study drug and have evaluable PK data for Clearance.
Pharmacokinetics -Clearance (Cl) of IMC-CS4.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=6 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
n=10 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
n=14 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
n=8 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Cycle 1 Day 1
|
0.0379 Liter per hour (L/h)
Geometric Coefficient of Variation 25
|
0.108 Liter per hour (L/h)
Geometric Coefficient of Variation 19
|
0.0715 Liter per hour (L/h)
Geometric Coefficient of Variation 28
|
0.0561 Liter per hour (L/h)
Geometric Coefficient of Variation 30
|
0.0566 Liter per hour (L/h)
Geometric Coefficient of Variation 35
|
0.0561 Liter per hour (L/h)
Geometric Coefficient of Variation 43
|
0.0534 Liter per hour (L/h)
Geometric Coefficient of Variation 34
|
—
|
—
|
|
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Cycle 1 Day 15
|
—
|
—
|
—
|
—
|
0.0530 Liter per hour (L/h)
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Cycle 1 Day 22
|
0.0195 Liter per hour (L/h)
Geometric Coefficient of Variation 40
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Cycle 3 Day 1
|
—
|
—
|
—
|
—
|
—
|
0.0210 Liter per hour (L/h)
Geometric Coefficient of Variation 67
|
NA Liter per hour (L/h)
Geometric Coefficient of Variation NA
Not analyzed due to insufficient number of participants.
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (6 Days)Population: All enrolled participants who received at least 1 dose of study drug.
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). A DLT is defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 4.0 Grade 4 neutropenia lasting ≥ 7 days, Grade 3 or 4 neutropenia complicated by fever ≥38.0°C or infection, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia complicated by hemorrhage, Grade 3 or 4 anemia, Grade ≥3 AST/ALT elevation, Grade ≥2 AST/ALT elevation and Grade ≥2 bilirubin elevation and Grade 3 or 4 nonhematologic toxicity. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=36 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Recommend Phase 2 Dose (RP2D) of IMC-CS4
|
100 milligrams/week
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up To 6 MonthsPopulation: All enrolled participants who received at least 1 dose of study drug and have baseline and post baseline data for anti-IMC-CS4 antibodies.
The overall percentage of participants with treatment-emergent positive for anti-IMC-CS4 antibodies during the study. Participants were considered positive for anti-IMC-CS4 antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the normal anti-IMC-CS4 level seen in healthy untreated individuals.
Outcome measures
| Measure |
2.5 mg/kg of IMC-CS4 QW
n=4 Participants
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
0.3 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
0.6 mg/kg of IMC-CS4 QW
n=3 Participants
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 QW
n=5 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
1.25 mg/kg of IMC-CS4 Q2W
n=3 Participants
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
100 mg of IMC-CS4 QW
n=4 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
150 mg of IMC-CS4 QW
n=3 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
n=11 Participants
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
n=9 Participants
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Anti-IMC-CS4 Antibody Assessment
|
50 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25 Percentage of Participants
|
0 Percentage of Participants
|
18.2 Percentage of Participants
|
0 Percentage of Participants
|
Adverse Events
Cohort 1 (2.5 mg/kg QW)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 2 (0.3 mg/kg QW)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Cohort 3 (0.6 mg/kg QW)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 4 (1.25 mg/kg Q2W)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Cohort 4 Expanded (1.25 mg/kg Q2W)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 5 (1.25 mg/kg QW)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 6a (100 mg QW)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 6a Expanded (100 mg QW)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 2 deaths
Cohort 7a (150 mg QW)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (2.5 mg/kg QW)
n=6 participants at risk
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 2 (0.3 mg/kg QW)
n=4 participants at risk
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 3 (0.6 mg/kg QW)
n=3 participants at risk
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 4 (1.25 mg/kg Q2W)
n=6 participants at risk
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
Cohort 4 Expanded (1.25 mg/kg Q2W)
n=5 participants at risk
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 5 (1.25 mg/kg QW)
n=5 participants at risk
Participants received 1.25 mg/kg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a (100 mg QW)
n=3 participants at risk
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
n=11 participants at risk
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
n=9 participants at risk
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Sudden death
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
Other adverse events
| Measure |
Cohort 1 (2.5 mg/kg QW)
n=6 participants at risk
Participants received 2.5 milligram per kilogram (mg/kg) of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 2 (0.3 mg/kg QW)
n=4 participants at risk
Participants received 0.3 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 3 (0.6 mg/kg QW)
n=3 participants at risk
Participants received 0.6 mg/kg of IMC-CS4 once weekly by intravenous infusion.
|
Cohort 4 (1.25 mg/kg Q2W)
n=6 participants at risk
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion.
|
Cohort 4 Expanded (1.25 mg/kg Q2W)
n=5 participants at risk
Participants received 1.25 mg/kg of IMC-CS4 every two weeks by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 5 (1.25 mg/kg QW)
n=5 participants at risk
Participants received 1.25 mg/kg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a (100 mg QW)
n=3 participants at risk
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion.
|
Cohort 6a Expanded (100 mg QW)
n=11 participants at risk
Participants received 100 mg of IMC-CS4 weekly once by intravenous infusion on weeks 1, 2, 4 and 5.
|
Cohort 7a (150 mg QW)
n=9 participants at risk
Participants received 150 mg of IMC-CS4 weekly once by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 6 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
60.0%
3/5 • Number of events 4 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 11 • Up To 6 Months
All enrolled participants
|
45.5%
5/11 • Number of events 8 • Up To 6 Months
All enrolled participants
|
55.6%
5/9 • Number of events 10 • Up To 6 Months
All enrolled participants
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 3 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 5 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 7 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Eye disorders
Eye swelling
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Eye disorders
Periorbital oedema
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
50.0%
2/4 • Number of events 8 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 4 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 5 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 2 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
33.3%
2/6 • Number of events 4 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
44.4%
4/9 • Number of events 6 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 6 • Up To 6 Months
All enrolled participants
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
General disorders
Chills
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Face oedema
|
33.3%
2/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Facial pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
50.0%
2/4 • Number of events 3 • Up To 6 Months
All enrolled participants
|
100.0%
3/3 • Number of events 5 • Up To 6 Months
All enrolled participants
|
83.3%
5/6 • Number of events 6 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 4 • Up To 6 Months
All enrolled participants
|
54.5%
6/11 • Number of events 10 • Up To 6 Months
All enrolled participants
|
55.6%
5/9 • Number of events 9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Localised oedema
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Medical device pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Oedema
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 5 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/1 • Up To 6 Months
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
0.00%
0/7 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
36.4%
4/11 • Number of events 27 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • Number of events 9 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
60.0%
3/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
63.6%
7/11 • Number of events 9 • Up To 6 Months
All enrolled participants
|
66.7%
6/9 • Number of events 9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood creatine phosphokinase bb increased
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood creatine phosphokinase increased
|
66.7%
4/6 • Number of events 10 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
45.5%
5/11 • Number of events 13 • Up To 6 Months
All enrolled participants
|
55.6%
5/9 • Number of events 12 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 5 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
2/6 • Number of events 4 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 4 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood phosphorus
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 5 • Up To 6 Months
All enrolled participants
|
36.4%
4/11 • Number of events 8 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 6 • Up To 6 Months
All enrolled participants
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 15 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 14 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 4 • Up To 6 Months
All enrolled participants
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Investigations
Red blood cells urine positive
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Respiratory rate increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Troponin increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Investigations
Urine output decreased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
50.0%
2/4 • Number of events 2 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Investigations
Weight increased
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 5 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Investigations
White blood cell count decreased
|
33.3%
2/6 • Number of events 4 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
45.5%
5/11 • Number of events 11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
75.0%
3/4 • Number of events 5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
36.4%
4/11 • Number of events 5 • Up To 6 Months
All enrolled participants
|
44.4%
4/9 • Number of events 6 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
40.0%
2/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 6 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
50.0%
2/4 • Number of events 2 • Up To 6 Months
All enrolled participants
|
100.0%
3/3 • Number of events 6 • Up To 6 Months
All enrolled participants
|
33.3%
2/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
60.0%
3/5 • Number of events 5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 5 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
33.3%
2/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
36.4%
4/11 • Number of events 6 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
33.3%
2/6 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
36.4%
4/11 • Number of events 6 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 4 • Up To 6 Months
All enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
60.0%
3/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 6 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 7 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
50.0%
2/4 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Haemoglobinuria
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 5 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/1 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
0.00%
0/1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
0.00%
0/7 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/1 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
0.00%
0/1 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/2 • Up To 6 Months
All enrolled participants
|
50.0%
1/2 • Number of events 1 • Up To 6 Months
All enrolled participants
|
14.3%
1/7 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
66.7%
2/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
100.0%
3/3 • Number of events 4 • Up To 6 Months
All enrolled participants
|
36.4%
4/11 • Number of events 4 • Up To 6 Months
All enrolled participants
|
33.3%
3/9 • Number of events 4 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 5 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
27.3%
3/11 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 2 • Up To 6 Months
All enrolled participants
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Embolism
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
25.0%
1/4 • Number of events 2 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
0.00%
0/9 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 3 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 5 • Up To 6 Months
All enrolled participants
|
16.7%
1/6 • Number of events 2 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 1 • Up To 6 Months
All enrolled participants
|
20.0%
1/5 • Number of events 3 • Up To 6 Months
All enrolled participants
|
33.3%
1/3 • Number of events 2 • Up To 6 Months
All enrolled participants
|
18.2%
2/11 • Number of events 2 • Up To 6 Months
All enrolled participants
|
22.2%
2/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
9.1%
1/11 • Number of events 1 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 3 • Up To 6 Months
All enrolled participants
|
|
Vascular disorders
Pallor
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/4 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/6 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/5 • Up To 6 Months
All enrolled participants
|
0.00%
0/3 • Up To 6 Months
All enrolled participants
|
0.00%
0/11 • Up To 6 Months
All enrolled participants
|
11.1%
1/9 • Number of events 1 • Up To 6 Months
All enrolled participants
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60