Trial Outcomes & Findings for A Study of LY2623091 in Healthy Participants (NCT NCT02300259)
NCT ID: NCT02300259
Last Updated: 2020-06-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdose
Results posted on
2020-06-26
Participant Flow
This study planned to enroll 3 groups. After Groups 1 and 2 were enrolled, data from Group 2 were analyzed according to a pre-specified algorithm. Results met criteria to enroll Group 4. (Group 3 was not enrolled.)
Participant milestones
| Measure |
LY2623091 + Itraconazole (Group 1)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Period 2: Oral doses of 200 mg itraconazole twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
Simvastatin + LY2623091 (Group 2)
Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
|
LY2623091 + Diltiazem (Group 4)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|
|
Period 1
STARTED
|
16
|
16
|
16
|
|
Period 1
Received at Least One Dose of Study Drug
|
16
|
16
|
16
|
|
Period 1
COMPLETED
|
16
|
16
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
2
|
|
Period 2
STARTED
|
16
|
0
|
14
|
|
Period 2
COMPLETED
|
15
|
0
|
13
|
|
Period 2
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
LY2623091 + Itraconazole (Group 1)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Period 2: Oral doses of 200 mg itraconazole twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
Simvastatin + LY2623091 (Group 2)
Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
|
LY2623091 + Diltiazem (Group 4)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
1
|
|
Period 2
Adverse Event
|
1
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2623091 in Healthy Participants
Baseline characteristics by cohort
| Measure |
LY2623091 + Itraconazole (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
Simvastatin + LY2623091 (Group 2)
n=16 Participants
Single oral dose of 20 mg simvastatin on Day 1 followed by oral doses of 24.5 mg LY2623091 QD on Days 3 to 13, with a single oral dose of 20 mg simvastatin coadministered on Day 12.
|
LY2623091 + Diltiazem (Group 4)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdosePopulation: All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable Cmax results.
Outcome measures
| Measure |
LY2623091 (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole + LY2623091 (Group 1)
n=16 Participants
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
LY2623091 (Group 4)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
.
|
Diltiazem + LY2623091 (Group 4)
n=14 Participants
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2623091
|
61.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
66.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
61.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
64.2 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
PRIMARY outcome
Timeframe: Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdosePopulation: All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-infinity) results.
Outcome measures
| Measure |
LY2623091 (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole + LY2623091 (Group 1)
n=16 Participants
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
LY2623091 (Group 4)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
.
|
Diltiazem + LY2623091 (Group 4)
n=14 Participants
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of LY2623091
|
2540 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
5660 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 31
|
2390 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39
|
3360 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 43
|
PRIMARY outcome
Timeframe: Group 1 (Days 1 and 6) Group 4 (Days 1 and 4): Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours (hr) postdose; additionally for Group 1 (Day 6): 264, 288, 312, 336, 360 hr postdosePopulation: All participants in Groups 1 and 4 who received at least one dose of study drug and had evaluable AUC(0-tlast) results.
Outcome measures
| Measure |
LY2623091 (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole + LY2623091 (Group 1)
n=15 Participants
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
LY2623091 (Group 4)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
.
|
Diltiazem + LY2623091 (Group 4)
n=14 Participants
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY2623091
|
2480 ng*hr/mL
Geometric Coefficient of Variation 27
|
5240 ng*hr/mL
Geometric Coefficient of Variation 31
|
2340 ng*hr/mL
Geometric Coefficient of Variation 39
|
3130 ng*hr/mL
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdosePopulation: All participants in Group 2 who received at least one dose of study drug and had evaluable Cmax results.
Outcome measures
| Measure |
LY2623091 (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole + LY2623091 (Group 1)
n=16 Participants
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
LY2623091 (Group 4)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
.
|
Diltiazem + LY2623091 (Group 4)
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|---|
|
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid
Simvastatin
|
7.78 ng/mL
Geometric Coefficient of Variation 63
|
9.89 ng/mL
Geometric Coefficient of Variation 45
|
—
|
—
|
|
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Simvastatin and Simvastatin Acid
Simvastatin Acid
|
0.720 ng/mL
Geometric Coefficient of Variation 41
|
0.877 ng/mL
Geometric Coefficient of Variation 55
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdosePopulation: All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-infinity) results.
Outcome measures
| Measure |
LY2623091 (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole + LY2623091 (Group 1)
n=16 Participants
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
LY2623091 (Group 4)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
.
|
Diltiazem + LY2623091 (Group 4)
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid
Simvastatin
|
17.4 ng*h/mL
Geometric Coefficient of Variation 48
|
24.1 ng*h/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Simvastatin and Simvastatin Acid
Simvastatin Acid
|
7.15 ng*h/mL
Geometric Coefficient of Variation 56
|
8.88 ng*h/mL
Geometric Coefficient of Variation 77
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 12: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdosePopulation: All participants in Group 2 who received at least one dose of study drug and had evaluable AUC(0-tlast) results.
Outcome measures
| Measure |
LY2623091 (Group 1)
n=16 Participants
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole + LY2623091 (Group 1)
n=16 Participants
Period 2: Oral doses of 200 mg itraconazole BID on Day 1 and then QD on Days 2 to 20 with a single oral dose of 6 mg LY2623091 coadministered on Day 6.
|
LY2623091 (Group 4)
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
.
|
Diltiazem + LY2623091 (Group 4)
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 to 13, with a single oral dose of 6 mg LY2623091 coadministered on Day 4.
|
|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid
Simvastatin
|
16.5 ng*hr/mL
Geometric Coefficient of Variation 49
|
23.0 ng*hr/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Simvastatin and Simvastatin Acid
Simvastatin Acid
|
5.42 ng*hr/mL
Geometric Coefficient of Variation 48
|
6.87 ng*hr/mL
Geometric Coefficient of Variation 87
|
—
|
—
|
Adverse Events
LY2623091 (Group 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Itraconazole (Group 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Itraconazole + LY2623091 (Group 1)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Simvastatin (Group 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LY2623091 (Group 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY2623091 + Simvastatin (Group 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LY2623091 (Group 4)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Diltiazem (Group 4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Diltiazem + LY2623091 (Group 4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2623091 (Group 1)
n=16 participants at risk
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Itraconazole (Group 1)
n=16 participants at risk
Period 2: Oral doses of 200 mg itraconazole BID on Days 1 through 5.
|
Itraconazole + LY2623091 (Group 1)
n=16 participants at risk
Period 2: Oral doses of 200 mg itraconazole and 6 mg LY2623091 coadministered once on Day 6.
|
Simvastatin (Group 2)
n=16 participants at risk
Single oral dose of 20 mg simvastatin on Day 1.
|
LY2623091 (Group 2)
n=16 participants at risk
Oral doses of 24.5 mg LY2623091 QD on Days 3 to 11.
|
LY2623091 + Simvastatin (Group 2)
n=16 participants at risk
Oral doses of 24.5 mg LY2623091 and 20 mg simvastatin coadministered once on Day 12.
|
LY2623091 (Group 4)
n=16 participants at risk
Period 1: Single oral dose of 6 mg LY2623091 on Day 1.
|
Diltiazem (Group 4)
n=14 participants at risk
Period 2: Oral doses of 240 mg diltiazem extended release QD on Days 1 through 3.
|
Diltiazem + LY2623091 (Group 4)
n=14 participants at risk
Period 2: Oral doses of 240 mg diltiazem extended release and 6 mg LY2623091 coadministered once on Day 4.
|
|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
12.5%
2/16 • Number of events 2
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 2
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
7.1%
1/14 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
7.1%
1/14 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
12.5%
2/16 • Number of events 2
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
7.1%
1/14 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
12.5%
2/16 • Number of events 3
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 2
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
General disorders
Cyst
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Infections and infestations
Viral infection
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
7.1%
1/14 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Nervous system disorders
Headache
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
12.5%
2/16 • Number of events 2
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
12.5%
2/16 • Number of events 2
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
6.2%
1/16 • Number of events 1
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/16
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
0.00%
0/14
Includes serious adverse events (SAEs) and all other non-serious adverse events (AEs) that met the frequency threshold regardless of causality.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60