Trial Outcomes & Findings for A Study of LY3076226 in Participants With Advanced or Metastatic Cancer (NCT NCT02529553)
NCT ID: NCT02529553
Last Updated: 2020-04-17
Results Overview
The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Cycle 1 (21 Days)
Results posted on
2020-04-17
Participant Flow
Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle.
Participant milestones
| Measure |
LY3076226-0.2mg/kg
Part A cohort 1 of dose escalation of LY3076226 at 0.2 milligram per killogram (mg/kg).
|
LY3076226-0.4mg/kg
Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
Part B dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
3
|
3
|
4
|
3
|
6
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
3
|
3
|
4
|
3
|
6
|
3
|
Reasons for withdrawal
| Measure |
LY3076226-0.2mg/kg
Part A cohort 1 of dose escalation of LY3076226 at 0.2 milligram per killogram (mg/kg).
|
LY3076226-0.4mg/kg
Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
Part B dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
0
|
1
|
3
|
2
|
3
|
3
|
5
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
Baseline characteristics by cohort
| Measure |
LY3076226-0.2mg/kg
n=1 Participants
Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg.
|
LY3076226-0.4mg/kg
n=1 Participants
Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
n=1 Participants
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
n=3 Participants
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
n=3 Participants
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
n=4 Participants
Part A cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
n=3 Participants
Part A cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
n=6 Participants
Part A cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
n=3 Participants
Part B dose expansion of LY3076226 at 5.0mg/kg.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
n=5 Participants
|
73.0 years
n=7 Participants
|
56.0 years
n=5 Participants
|
68.3 years
STANDARD_DEVIATION 1.5 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
63.0 years
STANDARD_DEVIATION 5.5 • n=8 Participants
|
72.7 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
65.8 years
STANDARD_DEVIATION 8.7 • n=24 Participants
|
56.3 years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
63.0 years
STANDARD_DEVIATION 9.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
19 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
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 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
|
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
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
22 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
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (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
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 Days)Population: All participants enrolled in dose escalation.
The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).
Outcome measures
| Measure |
LY3076226
n=22 Participants
Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1.
|
LY3076226-0.4mg/kg
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
Dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of LY3076226
|
5.0 milligrams
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hoursPopulation: All participants with adequate measurable PK concentrations.
Outcome measures
| Measure |
LY3076226
n=1 Participants
Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1.
|
LY3076226-0.4mg/kg
n=1 Participants
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
n=1 Participants
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
n=3 Participants
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
n=3 Participants
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
n=4 Participants
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
n=3 Participants
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
n=6 Participants
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
n=3 Participants
Dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Cycle 1
|
5.35 Micrograms per milliliter(μg/mL)
|
10.6 Micrograms per milliliter(μg/mL)
|
23.3 Micrograms per milliliter(μg/mL)
|
41.9 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 22.2
|
133 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 123
|
77.4 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 20.5
|
104 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 9.37
|
119 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 16.2
|
101 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 22.3
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Cycle 3
|
—
|
—
|
—
|
—
|
62.0 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 34.0
|
89.8 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 100
|
105 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 8.26
|
144 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 5.60
|
95.7 Micrograms per milliliter(μg/mL)
Geometric Coefficient of Variation 22.1
|
SECONDARY outcome
Timeframe: Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hoursPopulation: All participants with adequate measurable PK concentrations.
Outcome measures
| Measure |
LY3076226
n=1 Participants
Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1.
|
LY3076226-0.4mg/kg
n=1 Participants
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
n=1 Participants
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
n=3 Participants
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
n=3 Participants
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
n=4 Participants
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
n=3 Participants
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
n=6 Participants
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
n=3 Participants
Dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Cycle 1
|
13.0 μg per day per mL(μg/day/mL)
|
18.8 μg per day per mL(μg/day/mL)
|
112 μg per day per mL(μg/day/mL)
|
223 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 14.3
|
503 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 55.5
|
424 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 33.2
|
665 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 14.0
|
664 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 29.5
|
638 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 17.1
|
|
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Cycle 3
|
—
|
—
|
—
|
—
|
374 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 78.2
|
758 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 833
|
688 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 41.2
|
1120 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 18.9
|
801 μg per day per mL(μg/day/mL)
Geometric Coefficient of Variation 27.0
|
SECONDARY outcome
Timeframe: Baseline through Study Completion (Cycle 3, day 21)Population: All enrolled participants.
Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
LY3076226
n=1 Participants
Part A dose escalation of LY3076226 administered intravenously (IV) on day 1 of cycle 1.
|
LY3076226-0.4mg/kg
n=1 Participants
Cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
n=1 Participants
Cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
n=3 Participants
Cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
n=3 Participants
Cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
n=4 Participants
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
n=3 Participants
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
n=6 Participants
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
n=3 Participants
Dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Tumor Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
LY3076226-0.2mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY3076226-0.4mg/kg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
LY3076226-0.8mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY3076226-1.6mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
LY3076226-2.4mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
LY3076226-3.2mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY3076226-4.0mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LY3076226-5.0mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
LY3076226-5.0mg/kg Dose Expansion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY3076226-0.2mg/kg
n=1 participants at risk
Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg.
|
LY3076226-0.4mg/kg
n=1 participants at risk
Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
n=1 participants at risk
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
n=3 participants at risk
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
n=3 participants at risk
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
n=4 participants at risk
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
n=3 participants at risk
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
n=6 participants at risk
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
n=3 participants at risk
Part B dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
LY3076226-0.2mg/kg
n=1 participants at risk
Part A cohort 1 of dose escalation of LY3076226 at 0.2mg/kg.
|
LY3076226-0.4mg/kg
n=1 participants at risk
Part A cohort 2 of dose escalation of LY3076226 at 0.4mg/kg.
|
LY3076226-0.8mg/kg
n=1 participants at risk
Part A cohort 3 of dose escalation of LY3076226 at 0.8mg/kg.
|
LY3076226-1.6mg/kg
n=3 participants at risk
Part A cohort 4 of dose escalation of LY3076226 at 1.6mg/kg.
|
LY3076226-2.4mg/kg
n=3 participants at risk
Part A cohort 5 of dose escalation of LY3076226 at 2.4mg/kg.
|
LY3076226-3.2mg/kg
n=4 participants at risk
Cohort 6 of dose escalation of LY3076226 at 3.2mg/kg.
|
LY3076226-4.0mg/kg
n=3 participants at risk
Cohort 7 of dose escalation of LY3076226 at 4.0mg/kg.
|
LY3076226-5.0mg/kg
n=6 participants at risk
Cohort 8 of dose escalation of LY3076226 at 5.0mg/kg.
|
LY3076226-5.0mg/kg Dose Expansion
n=3 participants at risk
Part B dose expansion of LY3076226 at 5.0mg/kg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Eye disorders
Corneal epithelial microcysts
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Eye disorders
Keratitis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Eye disorders
Photopsia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal pigment epitheliopathy
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
3/3 • Number of events 6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
4/6 • Number of events 4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
3/3 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 8 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
3/3 • Number of events 4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasal vestibulitis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
100.0%
1/1 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 2 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/1 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
33.3%
2/6 • Number of events 3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 33 Days post study treatment
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60