Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants (NCT NCT02325791)
NCT ID: NCT02325791
Last Updated: 2018-11-06
Results Overview
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1177 participants
Primary outcome timeframe
Day 1 through Day 150
Results posted on
2018-11-06
Participant Flow
The study was conducted in 2 parts between 21-Jul-2015 and 26-Sep-2017. Part A of study was conducted at 6 sites in 3 countries and Part B was conducted at 175 sites in 18 countries. Only Part B of the study was conducted in Europe. A total of 23 participants were enrolled in Part A and a total of 1,154 participants were randomized in Part B.
In Part A, 27 participants were screened, of which 23 received study drug. In Part B, out of 1,154 participants, 1,149 received first dose of study drug. Of those, 1,051 continued and received second dose 8 weeks later. Participants were randomized in 1:1:1 ratio in Part B by gestational age category \& region (North America/Rest of World).
Participant milestones
| Measure |
Part A: Suptavumab 30 mg/kg
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Placebo Matched to Suptavumab
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
383
|
385
|
381
|
|
Overall Study
COMPLETED
|
23
|
358
|
360
|
355
|
|
Overall Study
NOT COMPLETED
|
0
|
25
|
25
|
26
|
Reasons for withdrawal
| Measure |
Part A: Suptavumab 30 mg/kg
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Placebo Matched to Suptavumab
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
15
|
14
|
9
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
5
|
8
|
16
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Baseline characteristics by cohort
| Measure |
Part A: Suptavumab 30 mg/kg
n=23 Participants
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Placebo Matched to Suptavumab
n=383 Participants
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=385 Participants
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
n=381 Participants
Participants received 2 doses of suptavumab 30 mg/kg IM:the first dose on Day 1 and the second dose on Day 57.
|
Total
n=1172 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=31 weeks 6 days
|
5 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
185 Participants
n=21 Participants
|
|
Age, Customized
>=32 weeks & <=35 weeks 6 days
|
18 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
322 Participants
n=4 Participants
|
987 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
546 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
626 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
239 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
302 Participants
n=4 Participants
|
919 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
326 Participants
n=4 Participants
|
1017 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 150Population: The PK analysis set included participants who received a single dose of suptavumab and had at least 1 measurable concentration of suptavumab in serum. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specific time point.
Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.
Outcome measures
| Measure |
Part A: Suptavumab 30 mg/kg - 1 Dose
n=22 Participants
Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 2
|
280 mg/L
Standard Deviation 92.9
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 8
|
177 mg/L
Standard Deviation 40.2
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 15
|
145 mg/L
Standard Deviation 28.7
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 22
|
128 mg/L
Standard Deviation 3.21
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 29
|
110 mg/L
Standard Deviation 10.3
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 57
|
70.9 mg/L
Standard Deviation 7.62
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 85
|
60.4 mg/L
Standard Deviation 14.0
|
—
|
—
|
|
Part A: Serum Concentration of Suptavumab Over Time
Day 150
|
15.9 mg/L
Standard Deviation 7.88
|
—
|
—
|
PRIMARY outcome
Timeframe: From first study drug administration up to Day 150Population: Full analysis set (FAS) included all randomized participants who received any study drug and was analyzed according to treatment allocated by Interactive voice response system (IVRS)/ Interactive web response system (IWRS) at randomization (as randomized).
A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room \[ER\], urgent care \[UC\], or pediatric clinic visits \[for either a sick or well visit\]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, \& with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation \<95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.
Outcome measures
| Measure |
Part A: Suptavumab 30 mg/kg - 1 Dose
n=383 Participants
Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=385 Participants
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
n=381 Participants
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|
|
Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150
|
8.1 Percentage of participants
|
7.7 Percentage of participants
|
9.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Day 150Population: Safety analysis set (SAF) included participants who received any dose of suptavumab.
Any untoward medical occurrence in participants, who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration \& date of end of study/last visit).Serious AE: Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious \& non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 \[severe\] \& Grade 4\[life-threatening\]) was used in this study to grade clinical AEs.
Outcome measures
| Measure |
Part A: Suptavumab 30 mg/kg - 1 Dose
n=23 Participants
Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|
|
Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any TEAE
|
69.6 Percentage of participants
|
—
|
—
|
|
Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Any Grade 3/Serious TEAE
|
4.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29, 57, 85, 113 and Day 150 Post-dosePopulation: The PK analysis set included participants who received a single dose of suptavumab and had at least 1 measurable concentration of suptavumab in serum. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specific time point.
Serum samples for drug concentration will be collected at pre-specified time points
Outcome measures
| Measure |
Part A: Suptavumab 30 mg/kg - 1 Dose
n=386 Participants
Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=334 Participants
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|
|
Part B: Serum Concentration of Suptavumab
Day 29
|
142 Milligram per liter (mg/L)
Standard Deviation 45.5
|
145 Milligram per liter (mg/L)
Standard Deviation 43.4
|
—
|
|
Part B: Serum Concentration of Suptavumab
Day 57
|
95.6 Milligram per liter (mg/L)
Standard Deviation 44.2
|
93.5 Milligram per liter (mg/L)
Standard Deviation 29.8
|
—
|
|
Part B: Serum Concentration of Suptavumab
Day 85
|
70.1 Milligram per liter (mg/L)
Standard Deviation 29.0
|
238 Milligram per liter (mg/L)
Standard Deviation 52.9
|
—
|
|
Part B: Serum Concentration of Suptavumab
Day 113
|
38.1 Milligram per liter (mg/L)
Standard Deviation 20.1
|
149 Milligram per liter (mg/L)
Standard Deviation 54.0
|
—
|
|
Part B: Serum Concentration of Suptavumab
Day 150
|
18.7 Milligram per liter (mg/L)
Standard Deviation 9.89
|
70.6 Milligram per liter (mg/L)
Standard Deviation 26.4
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 150Population: The ADA analysis set contained participants who received a single dose of suptavumab and had at least 1 post-treatment ADA result.
ADA category of each participant was classified as pre-existing immunoreactivity (a positive ADA response at baseline with a \<4-fold increase in titer for all post baseline samples), treatment-boosted (a positive response at baseline with at least one post baseline titer at \>=4-fold the baseline titer), or treatment-emergent (TE \[any positive post baseline assay response when baseline results were negative or missing\]). TE ADA responses were further classified as persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 12-week post baseline period \[based on nominal sampling time\], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point), indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), or transient (not persistent/indeterminate, regardless of any missing samples).
Outcome measures
| Measure |
Part A: Suptavumab 30 mg/kg - 1 Dose
n=363 Participants
Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=389 Participants
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
n=336 Participants
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|
|
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Negative/Pre-Existing
|
351 Participants
|
380 Participants
|
336 Participants
|
|
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Treatment Boosted
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Treatment-Emergent
|
12 Participants
|
9 Participants
|
0 Participants
|
|
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Treatment-Emergent: Persistent
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Treatment-Emergent: Transient
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Treatment-Emergent: Indeterminate
|
11 Participants
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first study drug administration up to Day 150Population: Analysis was performed on FAS population.
A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits \[for either a sick or well visit\]) with RSV LRTI. An RSV LRTI in an infant: RSV-proven respiratory infection (i.e, positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation \<95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit.
Outcome measures
| Measure |
Part A: Suptavumab 30 mg/kg - 1 Dose
n=383 Participants
Participants received a single dose of suptavumab 30 milligrams per kilogram (mg/kg) intramuscularly (IM) on Day 1.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=385 Participants
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
n=381 Participants
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|
|
Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150
|
12.5 Percentage of participants
|
11.9 Percentage of participants
|
14.5 Percentage of participants
|
Adverse Events
Part A: Suptavumab 30 mg/kg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part B: Placebo Matched to Suptavumab
Serious events: 44 serious events
Other events: 218 other events
Deaths: 3 deaths
Part B: Suptavumab 30 mg/kg- 1 Dose
Serious events: 54 serious events
Other events: 219 other events
Deaths: 1 deaths
Part B: Suptavumab 30 mg/kg - 2 Doses
Serious events: 29 serious events
Other events: 198 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Suptavumab 30 mg/kg
n=23 participants at risk
Participants received single dose of suptavumab 30 mg/kg IM on Day 1.
|
Part B: Placebo Matched to Suptavumab
n=384 participants at risk
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=418 participants at risk
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
n=348 participants at risk
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Cardiac disorders
Cardio-Respiratory arrest
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.52%
2/384 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Congenital, familial and genetic disorders
Amniotic band syndrome
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Congenital, familial and genetic disorders
Congenital inguinal hernia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.52%
2/384 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.86%
3/348 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Sandifer's syndrome
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
General disorders
Crying
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
General disorders
Death
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.72%
3/418 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
2.3%
9/384 • Number of events 9 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
2.4%
10/418 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
2.0%
7/348 • Number of events 7 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
1.0%
4/384 • Number of events 4 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.52%
2/384 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Pseudocroup
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
1.3%
5/384 • Number of events 6 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.1%
13/418 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.57%
2/348 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
1.2%
5/418 • Number of events 5 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Varicella
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Investigations
Respirovirus test positive
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye haemangioma
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intra-Abdominal haemangioma
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Nervous system disorders
Hypotonic-Hyporesponsive episode
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Nervous system disorders
Seizure
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.52%
2/384 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.48%
2/418 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Social circumstances
Child abuse
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.26%
1/384 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/418 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/348 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
Other adverse events
| Measure |
Part A: Suptavumab 30 mg/kg
n=23 participants at risk
Participants received single dose of suptavumab 30 mg/kg IM on Day 1.
|
Part B: Placebo Matched to Suptavumab
n=384 participants at risk
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
|
Part B: Suptavumab 30 mg/kg- 1 Dose
n=418 participants at risk
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
|
Part B: Suptavumab 30 mg/kg - 2 Doses
n=348 participants at risk
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
2/23 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.4%
13/384 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.8%
16/418 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.2%
11/348 • Number of events 11 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.2%
20/384 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
2.6%
11/418 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
4.0%
14/348 • Number of events 14 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.9%
15/384 • Number of events 16 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.7%
24/418 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.4%
12/348 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.3%
1/23 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
8.1%
31/384 • Number of events 32 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.0%
25/418 • Number of events 25 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.9%
24/348 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
General disorders
Pyrexia
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
8.1%
31/384 • Number of events 40 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
7.7%
32/418 • Number of events 37 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.3%
22/348 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Bronchiolitis
|
8.7%
2/23 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
4.2%
16/384 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
4.5%
19/418 • Number of events 27 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
7.8%
27/348 • Number of events 33 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.2%
24/384 • Number of events 32 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.7%
24/418 • Number of events 30 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.7%
13/348 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Conjunctivitis
|
4.3%
1/23 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
4.7%
18/384 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.0%
25/418 • Number of events 28 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.2%
18/348 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
13.8%
53/384 • Number of events 73 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
7.2%
30/418 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
10.1%
35/348 • Number of events 45 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Otitis media
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
7.6%
29/384 • Number of events 41 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
11.7%
49/418 • Number of events 84 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
7.5%
26/348 • Number of events 37 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Rhinitis
|
4.3%
1/23 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.6%
14/384 • Number of events 15 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
4.1%
17/418 • Number of events 18 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.2%
18/348 • Number of events 19 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
3/23 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
19.3%
74/384 • Number of events 102 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
22.0%
92/418 • Number of events 127 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
21.6%
75/348 • Number of events 119 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
13.0%
3/23 • Number of events 3 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.2%
20/384 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
4.5%
19/418 • Number of events 26 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.0%
21/348 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.7%
2/23 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.00%
0/384 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.24%
1/418 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
0.29%
1/348 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.6%
14/384 • Number of events 20 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.7%
24/418 • Number of events 27 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.6%
23/348 • Number of events 24 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
6.5%
25/384 • Number of events 35 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
5.7%
24/418 • Number of events 27 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
7.8%
27/348 • Number of events 33 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.7%
2/23 • Number of events 2 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
3.1%
12/384 • Number of events 13 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
1.9%
8/418 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
2.3%
8/348 • Number of events 8 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Part A: Day 150 and Part B: Day 237) regardless of seriousness or relationship to investigational product.
Reported AEs are TEAEs that developed/worsened during the 'on treatment period'. On treatment period for Part A: Day from first dose of drug to the End of study i.e. Day 150 \& for Part B: Day from first dose of drug up to the day of last dose of drug plus 180 days. Safety analysis set. Participant data was summarized according to treatment group.
|
Additional Information
Clinical Trial Management
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER