Trial Outcomes & Findings for FX-322 in Adults With Stable Sensorineural Hearing Loss (NCT NCT04120116)
NCT ID: NCT04120116
Last Updated: 2023-04-27
Results Overview
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Baseline to Day 210
Results posted on
2023-04-27
Participant Flow
Participant milestones
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
24
|
23
|
|
Overall Study
COMPLETED
|
22
|
24
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
|
Overall Study
Subject was deemed to not meet the inclusion criteria for SNHL after dose was administered
|
0
|
0
|
1
|
0
|
Baseline Characteristics
FX-322 in Adults With Stable Sensorineural Hearing Loss
Baseline characteristics by cohort
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=23 Participants
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=25 Participants
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=21 Participants
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=21 Participants
Four weekly intratympanic injections of placebo
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 Years
STANDARD_DEVIATION 8.93 • n=5 Participants
|
54.4 Years
STANDARD_DEVIATION 10.58 • n=7 Participants
|
51.0 Years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
55.1 Years
STANDARD_DEVIATION 10.52 • n=4 Participants
|
53.9 Years
STANDARD_DEVIATION 10.91 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
80 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
21 participants
n=5 Participants
|
21 participants
n=4 Participants
|
90 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 210Population: Full Analysis Set is defined as all randomized subjects who received at least one dose of study drug or placebo in the study ear per the randomized treatment schedule. Only data from subjects in the FAS that attended the Day 210 visit were analyzed for this endpoint. The FX-322 Pooled Group consists of subjects in the Groups 1, 2, and 3 combined. The Pooled Group is for analysis only and does not signify a separate randomized group of subjects.
Percent of subjects exceeding the Carney-Schlauch 95% confidence interval for improvement from baseline in number of words recognized from Consonant-Nucleus-Consonant (CNC) word lists
Outcome measures
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=21 Participants
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=24 Participants
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=19 Participants
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
FX-322 Pooled
n=64 Participants
All participants (Groups 1, 2, and 3 combined) receiving at least one dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=17 Participants
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|---|
|
Word Recognition in Quiet
|
23.8 Percent
|
16.7 Percent
|
15.8 Percent
|
18.8 Percent
|
41.2 Percent
|
PRIMARY outcome
Timeframe: Baseline to Day 210Population: Full Analysis Set is defined as all randomized subjects who received at least one dose of study drug or placebo in the study ear per the randomized treatment schedule. Only data from subjects in the FAS that attended the Day 210 visit were analyzed for this endpoint. The FX-322 Pooled Group consists of subjects in the Groups 1, 2, and 3 combined. The Pooled Group is for analysis only and does not signify a separate randomized group of subjects.
Mean absolute percent change in number of recognized words from CNC word lists
Outcome measures
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=21 Participants
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=24 Participants
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=19 Participants
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
FX-322 Pooled
n=64 Participants
All participants (Groups 1, 2, and 3 combined) receiving at least one dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=17 Participants
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|---|
|
Words-in-Noise
|
2.58 Percent change
Standard Deviation 7.251
|
3.33 Percent change
Standard Deviation 8.933
|
1.80 Percent change
Standard Deviation 7.236
|
2.63 Percent change
Standard Deviation 7.822
|
3.61 Percent change
Standard Deviation 11.259
|
PRIMARY outcome
Timeframe: Baseline to Day 210Population: Full Analysis Set is defined as all randomized subjects who received at least one dose of study drug or placebo in the study ear per the randomized treatment schedule. Only data from subjects in the FAS that attended the Day 210 visit were analyzed for this endpoint. FX-322 Pooled Group consists of subjects in the Groups 1, 2, and 3 combined. The Pooled Group is for analysis only and does not signify a separate randomized group of subjects.
Mean overall pure tone average (PTA) hearing thresholds in decibels (dB) derived by averaging the air conduction thresholds at 0.5, 1, 2 and 4kHZ frequencies
Outcome measures
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=21 Participants
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=24 Participants
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=19 Participants
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
FX-322 Pooled
n=64 Participants
All participants (Groups 1, 2, and 3 combined) receiving at least one dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=17 Participants
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|---|
|
Pure Tone Audiometry
|
54.92 Decibels (dB)
Standard Error 2.284
|
55.08 Decibels (dB)
Standard Error 2.175
|
52.44 Decibels (dB)
Standard Error 2.372
|
54.15 Decibels (dB)
Standard Error 1.417
|
52.90 Decibels (dB)
Standard Error 2.404
|
PRIMARY outcome
Timeframe: Baseline to Day 210Population: Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For TEAEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for TEAEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
Number of patients with treatment-related adverse events assessed by CTCAE v5.0
Outcome measures
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=24 Participants
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=25 Participants
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=21 Participants
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
FX-322 Pooled
n=23 Participants
All participants (Groups 1, 2, and 3 combined) receiving at least one dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=95 Participants
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
|
16 Participants
|
16 Participants
|
19 Participants
|
12 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 8, 15, 21 60, 90,150, and 210Population: Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For otoscopies, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed in the FX-322 Pooled Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
Number of treated ears with abnormalities of the external ear canal, tympanic membrane and middle ear at each specified time point
Outcome measures
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=24 Ears
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=25 Ears
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=21 Ears
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
FX-322 Pooled
n=72 Ears
All participants (Groups 1, 2, and 3 combined) receiving at least one dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=23 Ears
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|---|
|
Otoscopy Abnormalities
External - Baseline
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
1 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
External - Day 8
|
1 Number of ears
|
0 Number of ears
|
1 Number of ears
|
2 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
External - Day 15
|
2 Number of ears
|
0 Number of ears
|
1 Number of ears
|
3 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
External - Day 21
|
1 Number of ears
|
0 Number of ears
|
2 Number of ears
|
3 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
External - Day 60
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
External - Day 90
|
0 Number of ears
|
2 Number of ears
|
0 Number of ears
|
2 Number of ears
|
2 Number of ears
|
|
Otoscopy Abnormalities
External - Day 150
|
1 Number of ears
|
1 Number of ears
|
1 Number of ears
|
3 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
External - Day 210
|
1 Number of ears
|
0 Number of ears
|
1 Number of ears
|
2 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Baseline
|
1 Number of ears
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Day 8
|
2 Number of ears
|
3 Number of ears
|
1 Number of ears
|
7 Number of ears
|
2 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Day 15
|
4 Number of ears
|
1 Number of ears
|
2 Number of ears
|
7 Number of ears
|
4 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Day 21
|
2 Number of ears
|
1 Number of ears
|
3 Number of ears
|
6 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Day 60
|
0 Number of ears
|
1 Number of ears
|
0 Number of ears
|
1 Number of ears
|
2 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Day 90
|
0 Number of ears
|
1 Number of ears
|
0 Number of ears
|
1 Number of ears
|
2 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - Day 150
|
1 Number of ears
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
Tympanic membrane - 210
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Baseline
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 8
|
1 Number of ears
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 15
|
1 Number of ears
|
0 Number of ears
|
1 Number of ears
|
2 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 21
|
1 Number of ears
|
0 Number of ears
|
1 Number of ears
|
2 Number of ears
|
1 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 60
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 90
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 150
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Otoscopy Abnormalities
Middle Ear - Day 210
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
PRIMARY outcome
Timeframe: Baseline and Days 15, 60, 90, 150, 210Population: Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For tympanometry tests, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed in the FX-322 Pooled Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and thus was analyzed in Group 1
Number of treated ears with changes in middle ear compliance (mL), peak pressure (daPa), and/or ear canal volume (mL) from baseline
Outcome measures
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=24 Participants
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=25 Ears
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=21 Ears
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
FX-322 Pooled
n=72 Ears
All participants (Groups 1, 2, and 3 combined) receiving at least one dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=23 Ears
Four weekly intratympanic injections of placebo
|
|---|---|---|---|---|---|
|
Tympanometry Abnormalities
Baseline
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
1 Number of ears
|
2 Number of ears
|
|
Tympanometry Abnormalities
Day 15
|
2 Number of ears
|
0 Number of ears
|
4 Number of ears
|
6 Number of ears
|
4 Number of ears
|
|
Tympanometry Abnormalities
Day 60
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Tympanometry Abnormalities
Day 90
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Tympanometry Abnormalities
Day 150
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
0 Number of ears
|
|
Tympanometry Abnormalities
Day 210
|
0 Number of ears
|
0 Number of ears
|
1 Number of ears
|
1 Number of ears
|
0 Number of ears
|
Adverse Events
Group 1: FX-322 Single Dose, Placebo Three Doses
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 2: FX-322 Two Doses, Placebo Two Doses
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 3: FX-322 Four Doses
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Group 4: Placebo Four Doses
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Total
Serious events: 1 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=24 participants at risk
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=25 participants at risk
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=21 participants at risk
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=23 participants at risk
Four weekly intratympanic injections of placebo
|
Total
n=95 participants at risk
Combination of Group 1, Group 2, Group 3, Group 4, and two subjects randomized to Group 3 who only received 3 of 4 doses of FX-322
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Number of events 1 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
Other adverse events
| Measure |
Group 1: FX-322 Single Dose, Placebo Three Doses
n=24 participants at risk
Four weekly intratympanic injections:
One dose of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by three doses of placebo
|
Group 2: FX-322 Two Doses, Placebo Two Doses
n=25 participants at risk
Four weekly intratympanic injections:
Two doses of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg) followed by two doses of placebo
|
Group 3: FX-322 Four Doses
n=21 participants at risk
Four weekly intratympanic injections of FX-322 (laduviglusib 0.628 mg/sodium valproate 17.72 mg)
|
Group 4: Placebo Four Doses
n=23 participants at risk
Four weekly intratympanic injections of placebo
|
Total
n=95 participants at risk
Combination of Group 1, Group 2, Group 3, Group 4, and two subjects randomized to Group 3 who only received 3 of 4 doses of FX-322
|
|---|---|---|---|---|---|
|
General disorders
Discomfort
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Facial pain
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Hypoacusis
|
20.8%
5/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
20.0%
5/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
33.3%
7/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
17.4%
4/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
22.1%
21/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Ear discomfort
|
12.5%
3/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.0%
2/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
28.6%
6/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
12.6%
12/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Tinnitus
|
20.8%
5/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
12.0%
3/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
9.5%
9/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.0%
2/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.2%
4/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
3.2%
3/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Ear hemmorhage
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.7%
2/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
9.5%
2/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Injection site pain
|
8.3%
2/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
12.0%
3/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
14.3%
3/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.7%
2/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
10.5%
10/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Injection site scab
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
13.0%
3/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
5.3%
5/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Injection site hemorrhage
|
8.3%
2/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.2%
4/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Injection site discomfort
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
9.5%
2/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Fatigue
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Gait disturbance
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.0%
2/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.7%
2/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
5.3%
5/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Cystitis
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Eye infection
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Fungal infection
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Otitis externa fungal
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Otitis media
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Tooth abscess
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Dizziness
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
3.2%
3/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
3.2%
3/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
8.0%
2/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Dizziness postural
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Nystagmus
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Paraesthesia
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Retinal migraine
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Nervous system disorders
Visual field defect
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
9.5%
2/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Investigations
Audiogram abnormal
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
3.2%
3/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Investigations
Blood cholesterol increased
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Investigations
Blood pressure increased
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.3%
1/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Psychiatric disorders
Suicidal ideation
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
2.1%
2/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Vascular disorders
Flushing
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Eye disorders
Corneal irritation
|
4.2%
1/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Eye disorders
Glaucoma
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.8%
1/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/24 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
4.0%
1/25 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/21 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
0.00%
0/23 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
1.1%
1/95 • Baseline through Day 210
Safety Analysis Set (SAS) is defined as all subjects exposed to study drug or placebo. For AEs, subjects were analyzed per the treatment group that reflected the number of FX-322 doses actually administered. Two subjects who were initially randomized to Group 3 only received 3 of the 4 doses of FX-322 and were analyzed for AEs in the Total Group only. One subject who was initially randomized into Group 3 only received 1 of the 4 doses of FX-322 and therefore was analyzed in Group 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs must obtain sponsor's written consent before publishing or presenting the trial results
- Publication restrictions are in place
Restriction type: OTHER