Trial Outcomes & Findings for Notch Inhibitor in Advanced Cancer (NCT NCT01158404)
NCT ID: NCT01158404
Last Updated: 2019-08-09
Results Overview
Clinically significant effects are study drug related serious adverse events (SAEs) and study drug related treatment emergent adverse events (TEAEs). A summary of all SAEs and all other non-SAEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Baseline to study completion up to 18.7 weeks
Results posted on
2019-08-09
Participant Flow
Any participant who completed Cycle 1 or discontinued due to an adverse event (AE) in Part A is considered a completer. Any participant who completed cycle 1 or discontinued due to an AE or progressive disease in Part B was considered a completer.
Participant milestones
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
2 milligram (mg) LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Dose Escalation Phase (Part A)
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
6
|
5
|
3
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
4
|
3
|
3
|
6
|
5
|
3
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
4
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
3
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
2 milligram (mg) LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Dose Escalation Phase (Part A)
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
3
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Notch Inhibitor in Advanced Cancer
Baseline characteristics by cohort
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 Participants
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
n=6 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 Participants
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
n=8 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
66.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
62.5 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
58.4 years
STANDARD_DEVIATION 21.9 • n=10 Participants
|
55.7 years
STANDARD_DEVIATION 13.7 • n=115 Participants
|
57.5 years
STANDARD_DEVIATION 9.8 • n=24 Participants
|
58.8 years
STANDARD_DEVIATION 11.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
34 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
32 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion up to 18.7 weeksPopulation: All enrolled participants who received at least one dose of study drug.
Clinically significant effects are study drug related serious adverse events (SAEs) and study drug related treatment emergent adverse events (TEAEs). A summary of all SAEs and all other non-SAEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 Participants
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
n=6 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 Participants
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Part A: Dose Escalation
n=3 Participants
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
n=8 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects
TEAEs
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Effects
SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Predose up to 28 days in Cycle 1Population: All enrolled participants who received at least one dose of study drug during dose escalation phase.
Recommended Phase 2 dose was determined by the maximum tolerated dose (MTD). MTD is the highest dose with \<33% of participants having a dose-limiting toxicity (DLT) during Cycle 1. DLT is an adverse event (AE) occurring for a participant enrolled in Part A that is likely related to the study drug and fulfills any 1 of the following: Common Terminology Criteria for AE (CTCAE, Version 4.02) Grade 3 or 4 nonhematologic toxicity except for Grade 3 nausea, vomiting or electrolyte disturbance; Grade 3 nausea, vomiting or electrolyte disturbance that persists more than 2 days despite maximal supportive intervention; Grade 4 hematological toxicity that persists more than 5 days; Grade 3 or 4 thrombocytopenia with bleeding; Grade 3 or 4 neutropenia with fever. A DLT can be declared if a participant experiences increasing toxicity during treatment.
Outcome measures
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=27 Participants
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Part A: Dose Escalation
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Recommended Dose Range for Phase 2 Studies
|
30 milligrams (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to measured progressive disease up to 15.1 weeksPopulation: All enrolled participants who received at least one dose of study drug.
Best overall response of stable disease or better is complete response (CR) + partial response (PR) + stable disease (SD) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (version 1.1). CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Percentage of Participants with a best overall response of SD or better is calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated then multiplied by 100.
Outcome measures
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 Participants
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
n=6 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 Participants
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Part A: Dose Escalation
n=3 Participants
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
n=8 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Best Overall Response of Stable Disease or Better (Document the Antitumor Activity)
|
33.3 percentage of participants
|
0 percentage of participants
|
66.7 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dosePopulation: All enrolled participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate AUC(0-infinity).
The geometric mean AUC(0-infinity) for each dose group is reported following a single dose of LY900009.
Outcome measures
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=2 Participants
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 Participants
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
n=14 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 Participants
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Part A: Dose Escalation
n=3 Participants
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-time Curve of LY900009 From Time Zero to Infinity [AUC(0-infinity)]
|
NA nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation NA
For n=2, range (8.37 - 35.6) was reported.
|
31.6 nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation 48
|
76.2 nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation 123
|
121 nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation 59
|
315 nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation 71
|
547 nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation 32
|
1240 nanograms*hour/milliliters (ng*h/mL)
Geometric Coefficient of Variation 53
|
—
|
SECONDARY outcome
Timeframe: Day1: Pre-dose, 0.5 hours (hr), 1 hr, 3-4 hr, 6-8 hr and 24-30 hours post-dosePopulation: All enrolled participants who received the study drug and had sufficient pharmacokinetic (PK) data to calculate Cmax.
The geometric mean Cmax for each dose group is reported following a single dose of LY900009.
Outcome measures
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 Participants
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 Participants
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation Phase (Part A)
n=14 Participants
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 Participants
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Part A: Dose Escalation
n=3 Participants
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Confirmation Phase (Part B)
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY900009
|
4.03 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 122
|
11.7 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 70
|
20.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 68
|
27.4 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
71.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 104
|
96.2 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
158 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
—
|
Adverse Events
2 mg LY900009 - Dose Escalation Phase (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4 mg LY900009 - Dose Escalation Phase (Part A)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
8 mg LY900009 - Dose Escalation Phase (Part A)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
15 mg LY900009 - Dose Escalation Phase (Part A)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg LY900009 - Dose Escalation/Confirmation Phase (Part A,B)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
45 mg LY900009 - Dose Escalation Phase (Part A)
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
60 mg LY900009 - Dose Escalation Phase (Part A)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 participants at risk
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation/Confirmation Phase (Part A,B)
n=14 participants at risk
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 participants at risk
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
2 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
2 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
4 mg LY900009 - Dose Escalation Phase (Part A)
n=4 participants at risk
4 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
8 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
8 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
15 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
15 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
30 mg LY900009 - Dose Escalation/Confirmation Phase (Part A,B)
n=14 participants at risk
30 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
45 mg LY900009 - Dose Escalation Phase (Part A)
n=5 participants at risk
45 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
60 mg LY900009 - Dose Escalation Phase (Part A)
n=3 participants at risk
60 mg LY900009 administered orally 3 times per week (every Monday, Wednesday, and Friday) for 4 weeks of a 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
50.0%
2/4 • Number of events 4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
64.3%
9/14 • Number of events 9 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
60.0%
3/5 • Number of events 4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
42.9%
6/14 • Number of events 7 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
42.9%
6/14 • Number of events 6 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
21.4%
3/14 • Number of events 3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal infection
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
21.4%
3/14 • Number of events 3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
42.9%
6/14 • Number of events 6 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
40.0%
2/5 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hyposmia
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
66.7%
2/3 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
21.4%
3/14 • Number of events 3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 2 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
33.3%
1/3 • Number of events 1 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/14 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/5 • Up To 18.7 Weeks
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/3 • Up To 18.7 Weeks
All enrolled 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