Trial Outcomes & Findings for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (NCT NCT01496365)
NCT ID: NCT01496365
Last Updated: 2021-01-05
Results Overview
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
452 participants
Primary outcome timeframe
Baseline up to Week 5 postdose, up to 10 months total follow up
Results posted on
2021-01-05
Participant Flow
A total of 452 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized in the study at 80 clinic sites in the United States.
Participants were randomized to 1 of 7 treatment groups which included placebo, pregabalin 150 mg BID, DS-5565 5 mg QD, DS-5565 10 mg QD, DS-5565 15 mg QD, DS-5565 10 mg BID, and DS-5565 15 mg BID.
Participant milestones
| Measure |
Placebo
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
112
|
56
|
57
|
57
|
57
|
56
|
57
|
|
Overall Study
COMPLETED
|
97
|
41
|
51
|
53
|
44
|
46
|
51
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
6
|
4
|
13
|
10
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
2
|
5
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
0
|
1
|
3
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Other
|
4
|
4
|
2
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Placebo
n=112 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=56 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=57 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=57 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=57 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 9.40 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 9.85 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 9.92 • n=4 Participants
|
61.4 years
STANDARD_DEVIATION 8.70 • n=21 Participants
|
60.4 years
STANDARD_DEVIATION 8.59 • n=8 Participants
|
59.3 years
STANDARD_DEVIATION 8.54 • n=8 Participants
|
60.1 years
STANDARD_DEVIATION 9.26 • n=24 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
210 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
242 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
94 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
339 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=5 Participants
|
56 participants
n=7 Participants
|
57 participants
n=5 Participants
|
57 participants
n=4 Participants
|
57 participants
n=21 Participants
|
56 participants
n=8 Participants
|
57 participants
n=8 Participants
|
452 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: ADPS was assessed in the Full Analysis Set.
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
|
-1.86 units on a scale
Standard Deviation 2.18
|
-1.79 units on a scale
Standard Deviation 2.27
|
-2.04 units on a scale
Standard Deviation 2.22
|
-2.32 units on a scale
Standard Deviation 2.17
|
-2.66 units on a scale
Standard Deviation 2.37
|
-2.64 units on a scale
Standard Deviation 2.45
|
-2.79 units on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: ADPS was assessed in the Full Analysis Set.
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Week 1
|
-0.55 units on a scale
Interval -0.81 to -0.29
|
-1.10 units on a scale
Interval -1.49 to -0.72
|
-0.68 units on a scale
Interval -1.04 to -0.31
|
-0.95 units on a scale
Interval -1.31 to -0.58
|
-1.13 units on a scale
Interval -1.51 to -0.75
|
-1.26 units on a scale
Interval -1.62 to -0.89
|
-1.40 units on a scale
Interval -1.76 to -1.04
|
|
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Week 2
|
-1.12 units on a scale
Interval -1.47 to -0.77
|
-1.75 units on a scale
Interval -2.26 to -1.24
|
-1.38 units on a scale
Interval -1.86 to -0.89
|
-1.56 units on a scale
Interval -2.04 to -1.07
|
-1.76 units on a scale
Interval -2.28 to -1.25
|
-1.72 units on a scale
Interval -2.2 to -1.23
|
-2.33 units on a scale
Interval -2.8 to -1.85
|
|
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Week 3
|
-1.47 units on a scale
Interval -1.86 to -1.08
|
-1.79 units on a scale
Interval -2.36 to -1.21
|
-1.62 units on a scale
Interval -2.17 to -1.08
|
-1.78 units on a scale
Interval -2.32 to -1.23
|
-2.30 units on a scale
Interval -2.88 to -1.72
|
-2.38 units on a scale
Interval -2.93 to -1.82
|
-2.55 units on a scale
Interval -3.08 to -2.02
|
|
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Week 4
|
-1.67 units on a scale
Interval -2.08 to -1.26
|
-1.83 units on a scale
Interval -2.45 to -1.22
|
-2.01 units on a scale
Interval -2.59 to -1.44
|
-2.41 units on a scale
Interval -2.98 to -1.83
|
-2.46 units on a scale
Interval -3.08 to -1.85
|
-2.68 units on a scale
Interval -3.27 to -2.1
|
-2.72 units on a scale
Interval -3.29 to -2.15
|
|
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
End of treatment
|
-1.91 units on a scale
Interval -2.35 to -1.47
|
-1.87 units on a scale
Interval -2.53 to -1.21
|
-2.05 units on a scale
Interval -2.66 to -1.44
|
-2.40 units on a scale
Interval -3.01 to -1.8
|
-2.90 units on a scale
Interval -3.56 to -2.25
|
-2.87 units on a scale
Interval -3.49 to -2.24
|
-2.79 units on a scale
Interval -3.39 to -2.19
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: ADPS was assessed in the Full Analysis Set.
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Responder rate: ≥30% decrease from baseline · Yes
|
45 Participants
|
19 Participants
|
22 Participants
|
32 Participants
|
34 Participants
|
34 Participants
|
32 Participants
|
|
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Responder rate: ≥30% decrease from baseline · No
|
63 Participants
|
31 Participants
|
33 Participants
|
24 Participants
|
17 Participants
|
22 Participants
|
25 Participants
|
|
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Responder Rate: ≥50% decrease from baseline · Yes
|
26 Participants
|
14 Participants
|
11 Participants
|
16 Participants
|
20 Participants
|
24 Participants
|
25 Participants
|
|
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Responder Rate: ≥50% decrease from baseline · No
|
82 Participants
|
36 Participants
|
44 Participants
|
40 Participants
|
31 Participants
|
32 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: ADSIS was assessed in the Full Analysis Set.
Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = "pain did not interfere with sleep" to 10 = "pain completely interfered with sleep" over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=50 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
|
-1.98 units on a scale
Standard Deviation 2.38
|
-1.94 units on a scale
Standard Deviation 2.08
|
-2.19 units on a scale
Standard Deviation 2.35
|
-2.35 units on a scale
Standard Deviation 2.31
|
-2.97 units on a scale
Standard Deviation 2.57
|
-2.52 units on a scale
Standard Deviation 2.89
|
-2.69 units on a scale
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: SF-MPQ sensory and affective scores were assessed in the Full Analysis Set.
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Sensory score
|
-6.29 units on a scale
Standard Deviation 6.77
|
-5.94 units on a scale
Standard Deviation 7.32
|
-8.02 units on a scale
Standard Deviation 6.62
|
-8.73 units on a scale
Standard Deviation 6.70
|
-6.86 units on a scale
Standard Deviation 6.77
|
-6.56 units on a scale
Standard Deviation 7.42
|
-8.55 units on a scale
Standard Deviation 6.84
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Affective score
|
-2.10 units on a scale
Standard Deviation 2.93
|
-1.98 units on a scale
Standard Deviation 3.19
|
-2.35 units on a scale
Standard Deviation 2.80
|
-2.44 units on a scale
Standard Deviation 3.07
|
-1.84 units on a scale
Standard Deviation 2.28
|
-1.40 units on a scale
Standard Deviation 3.19
|
-2.23 units on a scale
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: SF-MPQ total score and VAS pain were assessed in the Full Analysis Set.
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=55 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=55 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=56 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Total score
|
-8.39 units on a scale
Standard Deviation 8.91
|
-7.92 units on a scale
Standard Deviation 9.89
|
-10.36 units on a scale
Standard Deviation 8.54
|
-11.16 units on a scale
Standard Deviation 9.29
|
-8.71 units on a scale
Standard Deviation 8.11
|
-7.96 units on a scale
Standard Deviation 9.77
|
-10.79 units on a scale
Standard Deviation 8.94
|
|
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
VAS pain
|
-20.84 units on a scale
Standard Deviation 25.12
|
-19.28 units on a scale
Standard Deviation 24.27
|
-27.40 units on a scale
Standard Deviation 22.52
|
-28.56 units on a scale
Standard Deviation 23.67
|
-28.73 units on a scale
Standard Deviation 26.73
|
-25.45 units on a scale
Standard Deviation 25.46
|
-32.82 units on a scale
Standard Deviation 26.97
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: SF-MPQ present pain intensity was assessed in the Full Analysis Set.
The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
|
-0.85 units on a scale
Standard Deviation 1.21
|
-0.84 units on a scale
Standard Deviation 0.96
|
-1.00 units on a scale
Standard Deviation 0.86
|
-1.04 units on a scale
Standard Deviation 1.23
|
-0.90 units on a scale
Standard Deviation 1.03
|
-0.73 units on a scale
Standard Deviation 1.34
|
-1.02 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: Modified BPI was assessed in the Full Analysis Set.
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
|
-1.5 units on a scale
Standard Deviation 2.11
|
-1.7 units on a scale
Standard Deviation 1.83
|
-1.6 units on a scale
Standard Deviation 1.97
|
-2.5 units on a scale
Standard Deviation 2.11
|
-2.4 units on a scale
Standard Deviation 2.35
|
-2.1 units on a scale
Standard Deviation 2.51
|
-2.6 units on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: Modified BPI was assessed in the Full Analysis Set.
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Worst Pain Intensity
|
-2.1 units on a scale
Standard Deviation 2.53
|
-1.9 units on a scale
Standard Deviation 2.61
|
-2.0 units on a scale
Standard Deviation 2.26
|
-2.6 units on a scale
Standard Deviation 2.53
|
-2.7 units on a scale
Standard Deviation 2.71
|
-2.3 units on a scale
Standard Deviation 3.06
|
-3.0 units on a scale
Standard Deviation 3.09
|
|
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Least Pain Intensity
|
-1.3 units on a scale
Standard Deviation 2.37
|
-0.9 units on a scale
Standard Deviation 1.98
|
-1.6 units on a scale
Standard Deviation 2.55
|
-1.7 units on a scale
Standard Deviation 2.69
|
-2.0 units on a scale
Standard Deviation 2.31
|
-1.0 units on a scale
Standard Deviation 2.58
|
-1.9 units on a scale
Standard Deviation 2.20
|
|
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average Pain Intensity
|
-1.7 units on a scale
Standard Deviation 2.16
|
-1.5 units on a scale
Standard Deviation 1.95
|
-1.7 units on a scale
Standard Deviation 2.18
|
-2.3 units on a scale
Standard Deviation 2.31
|
-2.0 units on a scale
Standard Deviation 2.34
|
-1.8 units on a scale
Standard Deviation 2.72
|
-2.3 units on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: Modified BPI was assessed in the Full Analysis Set.
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
|
-2.0 units on a scale
Standard Deviation 2.35
|
-1.8 units on a scale
Standard Deviation 1.94
|
-2.0 units on a scale
Standard Deviation 2.13
|
-2.5 units on a scale
Standard Deviation 2.44
|
-2.5 units on a scale
Standard Deviation 2.36
|
-2.0 units on a scale
Standard Deviation 3.09
|
-2.5 units on a scale
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: Modified BPI was assessed in the Full Analysis Set.
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
|
26.4 score on a scale
Standard Deviation 37.67
|
20.4 score on a scale
Standard Deviation 31.06
|
31.5 score on a scale
Standard Deviation 34.72
|
32.0 score on a scale
Standard Deviation 36.33
|
23.0 score on a scale
Standard Deviation 37.39
|
35.3 score on a scale
Standard Deviation 33.13
|
33.0 score on a scale
Standard Deviation 43.52
|
SECONDARY outcome
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow upPopulation: PGIC was assessed in the Full Analysis Set.
Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2).
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=51 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Overall status is much improved or better (score ≤2) · Yes
|
33 Participants
|
19 Participants
|
27 Participants
|
30 Participants
|
24 Participants
|
25 Participants
|
28 Participants
|
|
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Overall status is much improved or better (score ≤2) · No
|
73 Participants
|
31 Participants
|
28 Participants
|
25 Participants
|
26 Participants
|
27 Participants
|
28 Participants
|
|
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Overall status is minimally improved or better (score ≤3) · Yes
|
66 Participants
|
33 Participants
|
45 Participants
|
46 Participants
|
37 Participants
|
38 Participants
|
44 Participants
|
|
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Overall status is minimally improved or better (score ≤3) · No
|
40 Participants
|
17 Participants
|
10 Participants
|
9 Participants
|
13 Participants
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From the time of signing the informed consent form (ICF) up to 10 months postdosePopulation: Safety events were assessed in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1.
Outcome measures
| Measure |
Placebo
n=108 Participants
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 Participants
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 Participants
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 Participants
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=53 Participants
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 Participants
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 Participants
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Reproductive System and Breast Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Investigations
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Nausea
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Eye Disorders
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Vision blurred
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Weight increased
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Blood creatinine phosphokinase increased
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Constipation
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Oedema peripheral
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Gastrointestinal Disorders
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Drug-related TEAEs
|
31 Participants
|
35 Participants
|
24 Participants
|
21 Participants
|
40 Participants
|
34 Participants
|
37 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Participants with ≥1 drug-related TEAEs
|
20 Participants
|
14 Participants
|
13 Participants
|
12 Participants
|
17 Participants
|
18 Participants
|
19 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Nervous System Disorders
|
3 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
14 Participants
|
13 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Dizziness
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Somnolence
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Headache
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Balance disorder
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Amnesia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
General Disorders & Administration Site Conditions
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Fatigue
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Dry mouth
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Psychiatric Disorders
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Insomnia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Erectile dysfunction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Pregabalin 150 mg BID
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
DS-5565 5mg QD
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
DS-5565 10 mg QD
Serious events: 3 serious events
Other events: 28 other events
Deaths: 0 deaths
DS-5565 15 mg QD
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
DS-5565 10 mg BID
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
DS-5565 15 mg BID
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=108 participants at risk
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 participants at risk
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 participants at risk
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 participants at risk
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=53 participants at risk
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 participants at risk
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 participants at risk
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Renal failure acute
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Dyskinesia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Coronary artery disease
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Hepatobiliary disorders
Liver function test abnormal
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
Other adverse events
| Measure |
Placebo
n=108 participants at risk
Participants who were randomized to placebo.
|
Pregabalin 150 mg BID
n=50 participants at risk
Participants who were randomized to pregabalin 150 mg twice daily (BID).
|
DS-5565 5mg QD
n=55 participants at risk
Participants who were randomized to DS-5565 5 mg every day (QD).
|
DS-5565 10 mg QD
n=56 participants at risk
Participants who were randomized to DS-5565 10 mg every day (QD).
|
DS-5565 15 mg QD
n=53 participants at risk
Participants who were randomized to DS-5565 15 mg every day (QD).
|
DS-5565 10 mg BID
n=56 participants at risk
Participants who were randomized to DS-5565 10 mg twice daily (BID).
|
DS-5565 15 mg BID
n=57 participants at risk
Participants who were randomized to DS-5565 15 mg twice daily (BID).
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
6.0%
3/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
12.5%
7/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
11.3%
6/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
7.1%
4/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
15.8%
9/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Headache
|
3.7%
4/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
10.9%
6/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
7.1%
4/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
8.9%
5/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Somnolence
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
8.0%
4/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.7%
3/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
8.9%
5/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
12.3%
7/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.3%
3/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
8.9%
5/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.3%
3/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
7.1%
4/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.5%
3/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
4/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Oedema peripheral
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
8.0%
4/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
7.1%
4/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Fatigue
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
7.5%
4/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Weight increased
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.6%
5/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
8.0%
4/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
7.1%
4/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
5.4%
3/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Crying
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Dizziness exertional
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Formication
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Nervous system disorders
Aphthous stomatitis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Hemorrhoidal haemorrhage
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Pain
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Gait disturbance
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Inflammation
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Irritability
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Malaise
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Pyrexia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Sluggishness
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Tenderness
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Thirst
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Asthenia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Chills
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Feeling hot
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Gravitational oedema
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Influenza-like illness
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
General disorders
Local swelling
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood creatinine phosphokinase increased
|
2.8%
3/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Positive rombergism
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood chloride decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood creatinine increased
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood uric acid increased
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood urine present
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Creatinine renal clearance abnormal
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Heart rate increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Tandem gait test abnormal
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Troponin I increased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood pressure increased
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Blood urea increased
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Bronchitis
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Infections and infestations
Ear infection
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.6%
5/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
3/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascitiis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint lock
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Affect lability
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Depression
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Nervousness
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Psychiatric disorders
Anger
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.7%
4/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Eye disorders
Vision blurred
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
4.0%
2/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Eye disorders
Asthenopia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Eye disorders
Retinal tear
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Hypertension
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Hypotension
|
1.9%
2/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.6%
2/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Pyuria
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.8%
2/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
3.5%
2/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.8%
1/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
2.0%
1/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.93%
1/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/108 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/50 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/55 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
1.9%
1/53 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/56 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
0.00%
0/57 • Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place