Trial Outcomes & Findings for A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis (NCT NCT01723254)
NCT ID: NCT01723254
Last Updated: 2016-07-11
Results Overview
Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters \[cm\] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than \[\>\] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: \>10 cm or 21 caliper units and above).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
190 participants
Primary outcome timeframe
Within 14 days
Results posted on
2016-07-11
Participant Flow
Participant milestones
| Measure |
IGE-1 6 mcg
Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 20 mcg
Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 60 mcg
Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 200 mcg
Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 20 mcg
Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 60 mcg
Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 200 mcg
Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
Saline Placebo
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
21
|
20
|
20
|
20
|
20
|
20
|
63
|
|
Overall Study
COMPLETED
|
5
|
18
|
17
|
18
|
18
|
18
|
19
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
3
|
2
|
2
|
2
|
1
|
3
|
Reasons for withdrawal
| Measure |
IGE-1 6 mcg
Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 20 mcg
Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 60 mcg
Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 200 mcg
Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 20 mcg
Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 60 mcg
Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 200 mcg
Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
Saline Placebo
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Conflict with work schedule
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Personal issues
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
No longer have time to participate
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Move/Left to another country/city
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
1
|
0
|
1
|
1
|
1
|
2
|
Baseline Characteristics
A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
IGE-1 6 mcg
n=6 Participants
Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 Participants
Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
Saline Placebo
n=63 Participants
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 13.3 • n=93 Participants
|
31.6 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
35.7 years
STANDARD_DEVIATION 10.0 • n=27 Participants
|
33.5 years
STANDARD_DEVIATION 9.3 • n=483 Participants
|
35.4 years
STANDARD_DEVIATION 9.2 • n=36 Participants
|
35.9 years
STANDARD_DEVIATION 11.0 • n=10 Participants
|
33.6 years
STANDARD_DEVIATION 12.0 • n=115 Participants
|
34.7 years
STANDARD_DEVIATION 8.8 • n=40 Participants
|
34.4 years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
58 Participants
n=40 Participants
|
180 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Within 14 daysPopulation: All randomized participants who received at least one dose of study treatment.
Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters \[cm\] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than \[\>\] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: \>10 cm or 21 caliper units and above).
Outcome measures
| Measure |
IGE-1 6 mcg
n=6 Participants
Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 Participants
Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
Saline Placebo
n=63 Participants
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Any Redness
|
50.0 Percentage of participants
Interval 20.1 to 79.9
|
9.5 Percentage of participants
Interval 2.6 to 23.4
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
7.9 Percentage of participants
Interval 3.9 to 14.2
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Moderate and Severe Redness
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Any Swelling
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
14.3 Percentage of participants
Interval 5.4 to 29.1
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
9.5 Percentage of participants
Interval 5.1 to 16.1
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Mild Swelling
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
14.3 Percentage of participants
Interval 5.4 to 29.1
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
9.5 Percentage of participants
Interval 5.1 to 16.1
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Moderate Swelling
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Severe Swelling
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Any Pain
|
83.3 Percentage of participants
Interval 49.0 to 98.3
|
100.0 Percentage of participants
Interval 89.6 to 100.0
|
90.0 Percentage of participants
Interval 75.5 to 97.3
|
100.0 Percentage of participants
Interval 89.1 to 100.0
|
90.0 Percentage of participants
Interval 75.5 to 97.3
|
85.0 Percentage of participants
Interval 69.6 to 94.4
|
90.0 Percentage of participants
Interval 75.5 to 97.3
|
15.9 Percentage of participants
Interval 10.1 to 23.4
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Mild Pain
|
50.0 Percentage of participants
Interval 20.1 to 79.9
|
57.1 Percentage of participants
Interval 41.0 to 72.2
|
50.0 Percentage of participants
Interval 33.8 to 66.2
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
80.0 Percentage of participants
Interval 63.9 to 91.0
|
75.0 Percentage of participants
Interval 58.5 to 87.3
|
60.0 Percentage of participants
Interval 43.3 to 75.1
|
14.3 Percentage of participants
Interval 8.8 to 21.6
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Moderate Pain
|
33.3 Percentage of participants
Interval 9.3 to 66.7
|
38.1 Percentage of participants
Interval 23.6 to 54.4
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
70.0 Percentage of participants
Interval 53.3 to 83.4
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
1.6 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Severe Pain
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
4.8 Percentage of participants
Interval 0.5 to 17.3
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Any Local Reaction
|
83.3 Percentage of participants
Interval 49.0 to 98.3
|
100.0 Percentage of participants
Interval 89.6 to 100.0
|
90.0 Percentage of participants
Interval 75.5 to 97.3
|
100.0 Percentage of participants
Interval 89.1 to 100.0
|
95.0 Percentage of participants
Interval 81.9 to 99.5
|
85.0 Percentage of participants
Interval 69.6 to 94.4
|
90.0 Percentage of participants
Interval 75.5 to 97.3
|
25.4 Percentage of participants
Interval 18.3 to 33.8
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Any Severe Local Reaction
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
4.8 Percentage of participants
Interval 0.5 to 17.3
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Mild Redness
|
50.0 Percentage of participants
Interval 20.1 to 79.9
|
9.5 Percentage of participants
Interval 2.6 to 23.4
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
7.9 Percentage of participants
Interval 3.9 to 14.2
|
PRIMARY outcome
Timeframe: Within 14 daysPopulation: All randomized participants who received at least one dose of study treatment.
Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: \>2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to \[\>=\] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).
Outcome measures
| Measure |
IGE-1 6 mcg
n=6 Participants
Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 Participants
Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
Saline Placebo
n=63 Participants
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Fever
|
0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
1.6 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Fever
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
1.6 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Vomiting
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
4.8 Percentage of participants
Interval 1.8 to 10.3
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Vomiting
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
4.8 Percentage of participants
Interval 1.8 to 10.3
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Vomiting
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Vomiting
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Diarrhea
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
47.6 Percentage of participants
Interval 32.1 to 63.6
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
55.0 Percentage of participants
Interval 38.5 to 70.7
|
45.0 Percentage of participants
Interval 29.3 to 61.5
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
42.9 Percentage of participants
Interval 34.4 to 51.7
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Diarrhea
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
28.6 Percentage of participants
Interval 15.8 to 44.8
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
50.0 Percentage of participants
Interval 33.8 to 66.2
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
28.6 Percentage of participants
Interval 21.1 to 37.1
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Diarrhea
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
19.0 Percentage of participants
Interval 8.6 to 34.5
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
14.3 Percentage of participants
Interval 8.8 to 21.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Diarrhea
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Headache
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
81.0 Percentage of participants
Interval 65.5 to 91.4
|
55.0 Percentage of participants
Interval 38.5 to 70.7
|
70.0 Percentage of participants
Interval 53.3 to 83.4
|
75.0 Percentage of participants
Interval 58.5 to 87.3
|
60.0 Percentage of participants
Interval 43.3 to 75.1
|
55.0 Percentage of participants
Interval 38.5 to 70.7
|
65.1 Percentage of participants
Interval 56.3 to 73.1
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Headache
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
47.6 Percentage of participants
Interval 32.1 to 63.6
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
50.0 Percentage of participants
Interval 33.8 to 66.2
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
39.7 Percentage of participants
Interval 31.3 to 48.5
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Headache
|
.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
1.6 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Fatigue
|
50.0 Percentage of participants
Interval 20.1 to 79.9
|
61.9 Percentage of participants
Interval 45.6 to 76.4
|
85.0 Percentage of participants
Interval 69.6 to 94.4
|
85.0 Percentage of participants
Interval 69.6 to 94.4
|
70.0 Percentage of participants
Interval 53.3 to 83.4
|
60.0 Percentage of participants
Interval 43.3 to 75.1
|
65.0 Percentage of participants
Interval 48.2 to 79.3
|
66.7 Percentage of participants
Interval 57.9 to 74.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Fatigue
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
19.0 Percentage of participants
Interval 8.6 to 34.5
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
23.8 Percentage of participants
Interval 16.9 to 32.1
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Fatigue
|
33.3 Percentage of participants
Interval 9.3 to 66.7
|
42.9 Percentage of participants
Interval 27.8 to 59.0
|
55.0 Percentage of participants
Interval 38.5 to 70.7
|
45.0 Percentage of participants
Interval 29.3 to 61.5
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
42.9 Percentage of participants
Interval 34.4 to 51.7
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Fatigue
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Muscle Pain
|
66.7 Percentage of participants
Interval 33.3 to 90.7
|
71.4 Percentage of participants
Interval 55.2 to 84.2
|
75.0 Percentage of participants
Interval 58.5 to 87.3
|
75.0 Percentage of participants
Interval 58.5 to 87.3
|
70.0 Percentage of participants
Interval 53.3 to 83.4
|
50.0 Percentage of participants
Interval 33.8 to 66.2
|
60.0 Percentage of participants
Interval 43.3 to 75.1
|
34.9 Percentage of participants
Interval 26.9 to 43.7
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Muscle Pain
|
33.3 Percentage of participants
Interval 9.3 to 66.7
|
52.4 Percentage of participants
Interval 36.4 to 67.9
|
45.0 Percentage of participants
Interval 29.3 to 61.5
|
40.0 Percentage of participants
Interval 24.9 to 56.7
|
45.0 Percentage of participants
Interval 29.3 to 61.5
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
15.9 Percentage of participants
Interval 10.1 to 23.4
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Joint Pain
|
50.0 Percentage of participants
Interval 20.1 to 79.9
|
33.3 Percentage of participants
Interval 19.6 to 49.7
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
45.0 Percentage of participants
Interval 29.3 to 61.5
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
20.6 Percentage of participants
Interval 14.1 to 28.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Mild Joint Pain
|
33.3 Percentage of participants
Interval 9.3 to 66.7
|
28.6 Percentage of participants
Interval 15.8 to 44.8
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
12.7 Percentage of participants
Interval 7.5 to 19.8
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Fever
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Fever
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Headache
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
33.3 Percentage of participants
Interval 19.6 to 49.7
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
23.8 Percentage of participants
Interval 16.9 to 32.1
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Muscle Pain
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
19.0 Percentage of participants
Interval 8.6 to 34.5
|
30.0 Percentage of participants
Interval 16.6 to 46.7
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
25.0 Percentage of participants
Interval 12.7 to 41.5
|
20.0 Percentage of participants
Interval 9.0 to 36.1
|
35.0 Percentage of participants
Interval 20.7 to 51.8
|
19.0 Percentage of participants
Interval 12.8 to 26.9
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Muscle Pain
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Moderate Joint Pain
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
4.8 Percentage of participants
Interval 0.5 to 17.3
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
15.0 Percentage of participants
Interval 5.6 to 30.4
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
10.0 Percentage of participants
Interval 2.7 to 24.5
|
7.9 Percentage of participants
Interval 3.9 to 14.2
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Severe Joint Pain
|
0.0 Percentage of participants
Interval 0.0 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
0.0 Percentage of participants
Interval 0.0 to 3.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Systemic Reaction
|
66.7 Percentage of participants
Interval 33.3 to 90.7
|
100.0 Percentage of participants
Interval 89.6 to 100.0
|
90.0 Percentage of participants
Interval 75.5 to 97.3
|
100.0 Percentage of participants
Interval 89.1 to 100.0
|
95.0 Percentage of participants
Interval 81.9 to 99.5
|
85.0 Percentage of participants
Interval 69.6 to 94.4
|
85.0 Percentage of participants
Interval 69.6 to 94.4
|
82.5 Percentage of participants
Interval 74.8 to 88.6
|
|
Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Any Severe Systemic Reaction
|
16.7 Percentage of participants
Interval 1.7 to 51.0
|
0.0 Percentage of participants
Interval 0.0 to 10.4
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
0.0 Percentage of participants
Interval 0.0 to 10.9
|
5.0 Percentage of participants
Interval 0.5 to 18.1
|
1.6 Percentage of participants
Interval 0.2 to 6.0
|
PRIMARY outcome
Timeframe: Baseline up to 336 days post study administration or at Early TerminationPopulation: All randomized participants who received at least one dose of study treatment.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.
Outcome measures
| Measure |
IGE-1 6 mcg
n=6 Participants
Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 Participants
Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
Saline Placebo
n=63 Participants
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Permanent discontinuations due to TEAEs
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Participants with TEAEs
|
5 participants
|
18 participants
|
20 participants
|
20 participants
|
19 participants
|
19 participants
|
17 participants
|
55 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Participants with SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Participants with severe TEAEs
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Temporary discontinuations due to TEAEs
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Participants with treatment-related TEAEs
|
0 participants
|
2 participants
|
1 participants
|
4 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline up to 336 days post last study drug administration or Early TerminationPopulation: All randomized participants who received at least one dose of study treatment.
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.
Outcome measures
| Measure |
IGE-1 6 mcg
n=6 Participants
Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 Participants
Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
Saline Placebo
n=63 Participants
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
5 participants
|
9 participants
|
12 participants
|
13 participants
|
13 participants
|
12 participants
|
10 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)Population: All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.
Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.
Outcome measures
| Measure |
IGE-1 6 mcg
n=6 Participants
Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 Participants
Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=60 Participants
Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 Participants
Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 Participants
Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
|
Saline Placebo
n=63 Participants
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
Day 1 (n=6,21,20,20,20,20,20,62)
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
2002.8 units/milliliter (u/mL)
Interval 2002.8 to 2002.8
|
|
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
Day 182 (n=5,18,16,19,19,18,19,57)
|
11310.6 units/milliliter (u/mL)
Interval 5642.0 to 22674.9
|
44480.1 units/milliliter (u/mL)
Interval 30845.9 to 64141.0
|
72925.4 units/milliliter (u/mL)
Interval 49484.3 to 107470.7
|
126981.7 units/milliliter (u/mL)
Interval 88942.3 to 181290.0
|
35833.4 units/milliliter (u/mL)
Interval 25031.3 to 51296.9
|
41947.5 units/milliliter (u/mL)
Interval 29086.0 to 60496.1
|
106036.8 units/milliliter (u/mL)
Interval 73954.8 to 152036.2
|
2147.9 units/milliliter (u/mL)
Interval 1745.8 to 2642.7
|
|
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
Day 336 (n=5,18,16,17,18,16,6,52)
|
1896.7 units/milliliter (u/mL)
Interval 846.6 to 4248.9
|
17836.4 units/milliliter (u/mL)
Interval 11665.8 to 27271.1
|
22611.2 units/milliliter (u/mL)
Interval 14425.4 to 35442.0
|
42772.1 units/milliliter (u/mL)
Interval 27643.3 to 66180.7
|
9642.9 units/milliliter (u/mL)
Interval 6298.5 to 14763.1
|
12490.1 units/milliliter (u/mL)
Interval 7966.5 to 19582.1
|
43979.2 units/milliliter (u/mL)
Interval 20992.0 to 92138.2
|
2265.3 units/milliliter (u/mL)
Interval 1761.5 to 2913.2
|
Adverse Events
IGE-1 6 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IGE-1 20 mcg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
IGE-1 60 mcg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
IGE-1 200 mcg
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
IGE-2 20 mcg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
IGE-2 60 mcg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
IGE-2 200 mcg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 1 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IGE-1 6 mcg
n=6 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 participants at risk
Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 participants at risk
Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 participants at risk
Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
Saline Placebo
n=63 participants at risk
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
Other adverse events
| Measure |
IGE-1 6 mcg
n=6 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 20 mcg
n=21 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 60 mcg
n=20 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-1 200 mcg
n=20 participants at risk
Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 20 mcg
n=20 participants at risk
Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 60 mcg
n=20 participants at risk
Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
IGE-2 200 mcg
n=20 participants at risk
Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 \[TLR9\] agonist) in combination as adjuvants.
|
Saline Placebo
n=63 participants at risk
Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastric infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Vulvovaginitis
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/2 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
1/5 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Malaria
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
19.0%
4/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
30.0%
6/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.9%
10/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
2/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
6.3%
4/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Tinea pedis
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Vaginal infection
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/2 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
1/5 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
33.3%
7/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
50.0%
10/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
55.0%
11/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
40.0%
8/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
55.0%
11/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
30.0%
6/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
41.3%
26/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
6/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Intestinal polyp
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
25.0%
5/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
7.9%
5/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
6.3%
4/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Chills
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Facial pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Local swelling
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Bacterial infection
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Blister infected
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
2/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle mass
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
2/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
17.5%
11/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
23.8%
5/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
30.0%
6/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
17.5%
11/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
2/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
4/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
35.0%
7/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
6/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Chondrolysis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
2/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
6.3%
4/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
9.5%
2/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
15.0%
3/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Psychiatric disorders
Stress
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
1/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Reproductive system and breast disorders
Penile blister
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/19 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/19 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/19 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/18 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/58 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/1 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/2 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
—
0/0 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
20.0%
1/5 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
4.8%
3/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
14.3%
9/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
10.0%
2/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
1.6%
1/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
3.2%
2/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/21 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
5.0%
1/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/20 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
0.00%
0/63 • Baseline up to 336 days post study administration or at Early Termination
All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER