Trial Outcomes & Findings for A Multiple Dose Study of LY3502970 in Healthy Participants (NCT NCT05051566)
NCT ID: NCT05051566
Last Updated: 2026-05-29
Results Overview
Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Results posted on
2026-05-29
Participant Flow
The study was conducted in 2 parts: Part A: This is the initial formulation evaluation phase, where multiple oral doses of LY3502970 formulation prototypes were tested in a group of participants. Part B: This is the secondary evaluation phase in another group of participants, where, depending on the results of Part A, one of the prototypes may be further evaluated with regard to the effects of food, proton pump inhibitors (PPIs), or additional prototype formulations may be explored.
Participant milestones
| Measure |
Part A
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD)
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
Part B
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD.
* Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD.
* Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI (40 mg Esomeprazole tablet) first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK parameters were evaluated under these elevated gastric pH conditions.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
|
Overall Study
Received at Least 1 Dose of Study Drug (Safety Analyses Set)
|
12
|
14
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Part A
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD)
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
Part B
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD.
* Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD.
* Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI (40 mg Esomeprazole tablet) first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK parameters were evaluated under these elevated gastric pH conditions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
Baseline Characteristics
A Multiple Dose Study of LY3502970 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A (LY3502970)
n=12 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
Part B (LY3502970)
n=14 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD.
* Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD.
* Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH, and PK parameters were evaluated under these elevated gastric pH conditions.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=51 Participants
|
14 Participants
n=14 Participants
|
26 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=51 Participants
|
13 Participants
n=14 Participants
|
22 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=51 Participants
|
14 Participants
n=14 Participants
|
26 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=51 Participants
|
14 Participants
n=14 Participants
|
25 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)Population: All part A participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Outcome measures
| Measure |
Part A (LY3502970)
n=10 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
|---|---|
|
Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg reference capsule (Day 24)
|
66.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 77.4
|
|
Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 1 tablet (Days 30 and 36)
|
111 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 81.2
|
|
Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Days 30 and 36)
|
97.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 58.9
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)Population: All part A participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Outcome measures
| Measure |
Part A (LY3502970)
n=10 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
|---|---|
|
Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg reference capsule (Day 24)
|
988 nanogram*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 66.9
|
|
Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 1 tablet (Days 30 and 36)
|
1480 nanogram*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 75.2
|
|
Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Days 30 and 36)
|
1400 nanogram*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 51.2
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)Population: All part A participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).
Outcome measures
| Measure |
Part A (LY3502970)
n=10 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
|---|---|
|
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg reference capsule (Day 24)
|
7.02 hours
Interval 4.0 to 8.0
|
|
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 1 tablet (Days 30 and 36)
|
8 hours
Interval 4.0 to 16.0
|
|
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Days 30 and 36)
|
8 hours
Interval 4.0 to 16.0
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)Population: All part B participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Outcome measures
| Measure |
Part A (LY3502970)
n=12 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
|---|---|
|
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)
|
59.6 ng/mL
Geometric Coefficient of Variation 51.0
|
|
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Fasted) (Day 24)
|
63.4 ng/mL
Geometric Coefficient of Variation 32.2
|
|
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Fed) (Day 30)
|
56.3 ng/mL
Geometric Coefficient of Variation 29.6
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)Population: All part B participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Outcome measures
| Measure |
Part A (LY3502970)
n=12 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
|---|---|
|
Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Fasted) (Day 24)
|
903 ng*h/mL
Geometric Coefficient of Variation 25.3
|
|
Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Fed) (Day 30)
|
865 ng*h/mL
Geometric Coefficient of Variation 24.6
|
|
Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)
|
956 ng*h/mL
Geometric Coefficient of Variation 40.1
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)Population: All part B participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.
Outcome measures
| Measure |
Part A (LY3502970)
n=12 Participants
* Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received daily doses of LY3502970 oral capsule, with the dose escalation every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
* Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule QD.
* Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
|
|---|---|
|
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Fasted) (Day 24)
|
8.00 hours
Interval 4.0 to 12.0
|
|
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg prototype 2 tablet (Fed) (Day 30)
|
7.00 hours
Interval 2.0 to 16.05
|
|
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
16 mg Prototype 2 tablet + PPI (Fasted) (Day 36)
|
7.00 hours
Interval 4.0 to 12.0
|
Adverse Events
Part B - 2 mg Capsule
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part B - 4 mg Capsule
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part B - 8 mg Capsule
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part B -16 mg Prototype 2 Tablet/Fasted
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Part B - 16 mg Prototype 2 Tablet/Fed
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B - 16 mg Prototype 2 Tablet + PPI
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A - 16 mg Prototype 2 Tablet
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A - 2 mg Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A - 4 mg Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A - 8 mg Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A - 16 mg Capsule
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part A - 16 mg Prototype 1 Tablet
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part B - 2 mg Capsule
n=14 participants at risk
Part B participants who received 2 mg LY3502970 capsule were grouped in this arm.
|
Part B - 4 mg Capsule
n=14 participants at risk
Part B participants who received 4 mg LY3502970 capsule were grouped in this arm.
|
Part B - 8 mg Capsule
n=14 participants at risk
Part B participants who received 8 mg LY3502970 capsule were grouped in this arm.
|
Part B -16 mg Prototype 2 Tablet/Fasted
n=14 participants at risk
Part B participants who received 16 mg LY3502970 prototype 2 tablet in fasted stage were grouped in this arm.
|
Part B - 16 mg Prototype 2 Tablet/Fed
n=12 participants at risk
Part B participants who received 16 mg LY3502970 prototype 2 tablet in fed stage were grouped in this arm.
|
Part B - 16 mg Prototype 2 Tablet + PPI
n=12 participants at risk
Part B participants who received 16 mg LY3502970 prototype 2 tablet together with PPI Esomeprazole in fasted stage were grouped in this arm.
|
Part A - 16 mg Prototype 2 Tablet
n=10 participants at risk
Part A participants who received 16 mg LY3502970 prototype 2 tablet were grouped in this arm.
|
Part A - 2 mg Capsule
n=12 participants at risk
Part A participants who received 2 mg LY3502970 capsule were grouped in this arm.
|
Part A - 4 mg Capsule
n=12 participants at risk
Part A participants who received 4 mg LY3502970 capsule were grouped in this arm.
|
Part A - 8 mg Capsule
n=12 participants at risk
Part A participants who received 8 mg LY3502970 capsule were grouped in this arm.
|
Part A - 16 mg Capsule
n=11 participants at risk
Part A participants who received 16 mg LY3502970 capsule were grouped in this arm.
|
Part A - 16 mg Prototype 1 Tablet
n=10 participants at risk
Part A participants who received 16 mg LY3502970 prototype 1 tablet were grouped in this arm.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
7/14 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
28.6%
4/14 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
25.0%
3/12 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
60.0%
6/10 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
58.3%
7/12 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
50.0%
6/12 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
50.0%
6/12 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
72.7%
8/11 • Number of events 8 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
50.0%
5/10 • Number of events 10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
33.3%
4/12 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
18.2%
2/11 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Chest discomfort
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Lip dry
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Early satiety
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
30.0%
3/10 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Hunger
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Influenza like illness
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Malaise
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
General disorders
Thirst
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Infections and infestations
Covid-19
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Amylase increased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Lipase increased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
66.7%
8/12 • Number of events 8 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
6/14 • Number of events 6 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
41.7%
5/12 • Number of events 5 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
16.7%
2/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
25.0%
3/12 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
16.7%
2/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
16.7%
2/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
30.0%
3/10 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
28.6%
4/14 • Number of events 6 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
50.0%
6/12 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
25.0%
3/12 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
33.3%
4/12 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
18.2%
2/11 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
30.0%
3/10 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Hyperaesthesia
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Somnolence
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Nervous system disorders
Tremor
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Renal and urinary disorders
Ketonuria
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Renal and urinary disorders
Polyuria
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Vascular disorders
Flushing
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Eye disorders
Ocular hyperaemia
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
16.7%
2/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
18.2%
2/11 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Abdominal distension
|
28.6%
4/14 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
33.3%
4/12 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
20.0%
2/10 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
7/14 • Number of events 7 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
41.7%
5/12 • Number of events 5 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
33.3%
4/12 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
27.3%
3/11 • Number of events 4 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
18.2%
2/11 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
2/14 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
21.4%
3/14 • Number of events 3 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
7.1%
1/14 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
16.7%
2/12 • Number of events 2 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
9.1%
1/11 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
10.0%
1/10 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/14 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
8.3%
1/12 • Number of events 1 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/12 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/11 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
0.00%
0/10 • Baseline to the end of follow-up (up to Day 53)
All participants from the safety analyses set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60