Trial Outcomes & Findings for MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects (NCT NCT02013388)
NCT ID: NCT02013388
Last Updated: 2016-12-21
Results Overview
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
21 Days
Results posted on
2016-12-21
Participant Flow
Participant milestones
| Measure |
Placebo
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo-single Dose
Placebo: Given PO daily for 1 day
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
6
|
6
|
6
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
5
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo-single Dose
Placebo: Given PO daily for 1 day
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
work emergency
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 Participants
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 Participants
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=6 Participants
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
n=6 Participants
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
n=6 Participants
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
n=6 Participants
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
n=4 Participants
single oral dose Placebo: Given PO daily for 1day
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 12.32 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 14.90 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 14.25 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 10.03 • n=4 Participants
|
37.3 years
STANDARD_DEVIATION 10.91 • n=21 Participants
|
42.3 years
STANDARD_DEVIATION 9.40 • n=8 Participants
|
37.8 years
STANDARD_DEVIATION 11.84 • n=8 Participants
|
41.3 years
STANDARD_DEVIATION 11.59 • n=24 Participants
|
39.1 years
STANDARD_DEVIATION 11.40 • n=42 Participants
|
|
Gender
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Gender
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
33 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 21 DaysPopulation: All patients enrolled in the study were evaluated for safety endpoints
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Outcome measures
| Measure |
Placebo
n=9 Participants
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 Participants
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 Participants
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=6 Participants
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
n=6 Participants
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
n=6 Participants
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
n=6 Participants
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
n=4 Participants
single oral dose Placebo: Given PO daily for 1day
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of N91115
Subjects with at least one TEAE
|
9 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Safety and Tolerability of N91115
Subjects with at least one study treatment TEAE
|
5 participants
|
4 participants
|
4 participants
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 1Population: All patients that had plasma samples collected were included in the analysis
Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
Outcome measures
| Measure |
Placebo
n=6 Participants
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 Participants
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 Participants
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=5 Participants
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
single oral dose Placebo: Given PO daily for 1day
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Day 1 AUClast
|
327 h*ng/mL
Geometric Coefficient of Variation 24.0
|
1530 h*ng/mL
Geometric Coefficient of Variation 23.5
|
12000 h*ng/mL
Geometric Coefficient of Variation 20.6
|
32400 h*ng/mL
Geometric Coefficient of Variation 44.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All patients that completed the required days of dosing to study end
Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Outcome measures
| Measure |
Placebo
n=6 Participants
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 Participants
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 Participants
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=5 Participants
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
single oral dose Placebo: Given PO daily for 1day
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: AUCtau Day 14
|
423 h*ng/mL
Geometric Coefficient of Variation 17.1
|
2240 h*ng/mL
Geometric Coefficient of Variation 23.4
|
14500 h*ng/mL
Geometric Coefficient of Variation 17.9
|
36000 h*ng/mL
Geometric Coefficient of Variation 41.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects that completed the plasma collection sampling were included in the analysis
All subjects who completed sample collections for Day 1 plasma N91115
Outcome measures
| Measure |
Placebo
n=6 Participants
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 Participants
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 Participants
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=5 Participants
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
single oral dose Placebo: Given PO daily for 1day
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Day 1 Plasma Cmax Values
|
33.0 ng/mL
Geometric Coefficient of Variation 32.2
|
245 ng/mL
Geometric Coefficient of Variation 55.4
|
1810 ng/mL
Geometric Coefficient of Variation 50.2
|
3840 ng/mL
Geometric Coefficient of Variation 39.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: All subjects completing plasma collection sampling for N91115
Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Outcome measures
| Measure |
Placebo
n=6 Participants
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 Participants
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 Participants
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=5 Participants
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
single oral dose Placebo: Given PO daily for 1day
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Plasma Cmax Values on Day 14
|
84.3 ng/mL
Geometric Coefficient of Variation 44.4
|
445 ng/mL
Geometric Coefficient of Variation 48.6
|
2410 ng/mL
Geometric Coefficient of Variation 30.3
|
5800 ng/mL
Geometric Coefficient of Variation 67.2
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
10 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
250 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
500 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
50 mg (Single Dose)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
250 mg (Fed)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo- Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
single oral daily dose of placebo for 14 days
Placebo: Given PO daily for 14 days
|
10 mg
n=6 participants at risk
single oral daily dose of 10 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg
n=6 participants at risk
single oral daily dose of 50 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
250 mg
n=6 participants at risk
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115: Given PO daily for 14 days
|
500 mg
n=6 participants at risk
single oral daily dose of 500 mg N91115 for 14 days
N91115: Given PO daily for 14 days
|
50 mg (Single Dose)
n=6 participants at risk
single oral dose of 50 mg N91115
N91115: Given PO only on Day 1
|
250 mg (Fed)
n=6 participants at risk
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115: Given PO only on Day 1
|
Placebo- Single Dose
n=4 participants at risk
single oral dose Placebo: Given PO daily for 1day
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitation
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
11.1%
1/9 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Gastrointestinal disorders
Change Of Bowel Habit
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
11.1%
1/9 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
50.0%
3/6 • Number of events 3 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
33.3%
2/6 • Number of events 2 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Renal and urinary disorders
Urine Odor Abnormal
|
11.1%
1/9 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
100.0%
9/9 • Number of events 9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
100.0%
6/6 • Number of events 6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
100.0%
6/6 • Number of events 6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
100.0%
6/6 • Number of events 6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
100.0%
6/6 • Number of events 6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
66.7%
4/6 • Number of events 4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
25.0%
1/4 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/9 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
16.7%
1/6 • Number of events 1 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/6 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
0.00%
0/4 • AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
|
Additional Information
Nivalis Therapeutics, Inc. (Formerly N30 Pharma)
Nivalis Therapeutics, Inc.
Phone: 720-945-7700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60