Trial Outcomes & Findings for A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (NCT NCT04427501)
NCT ID: NCT04427501
Last Updated: 2024-04-11
Results Overview
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
3307 participants
Primary outcome timeframe
Baseline through Day 29
Results posted on
2024-04-11
Participant Flow
This study has three parts: Phase 2, Phase 3 and pediatrics addendum. All participants in Placebo for Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab are also in Placebo For Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab therefore the two arms are combined to avoid double counting.
Participant milestones
| Measure |
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
|
Phase 2: 700 mg Bamlanivimab
Participants received 700 milligram (mg) bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab administered IV.
|
Phase 2: 7000 mg Bamlanivimab
Participants received 7000 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
|
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
156
|
101
|
107
|
101
|
112
|
776
|
518
|
513
|
141
|
213
|
94
|
17
|
|
Overall Study
Received at Least One Dose of Study Drug
|
156
|
101
|
107
|
101
|
112
|
776
|
518
|
513
|
141
|
213
|
94
|
17
|
|
Overall Study
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
|
0
|
0
|
0
|
0
|
0
|
517
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
|
0
|
0
|
0
|
0
|
0
|
776
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
141
|
95
|
103
|
98
|
103
|
719
|
485
|
496
|
135
|
207
|
88
|
16
|
|
Overall Study
NOT COMPLETED
|
15
|
6
|
4
|
3
|
9
|
57
|
33
|
17
|
6
|
6
|
6
|
1
|
Reasons for withdrawal
| Measure |
Phase 2: Placebo
Participants received Placebo administered intravenously (IV).
|
Phase 2: 700 mg Bamlanivimab
Participants received 700 milligram (mg) bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab
Participants received 2800 mg bamlanivimab administered IV.
|
Phase 2: 7000 mg Bamlanivimab
Participants received 7000 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
|
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
2
|
0
|
2
|
11
|
10
|
10
|
2
|
5
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
3
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
2
|
2
|
3
|
7
|
25
|
15
|
7
|
4
|
1
|
4
|
0
|
|
Overall Study
Other - as reported by the investigator
|
1
|
0
|
0
|
0
|
0
|
6
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
Baseline characteristics by cohort
| Measure |
Phase 2: Placebo
n=156 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 2: 700 mg Bamlanivimab
n=101 Participants
Participants received 700 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab
n=107 Participants
Participants received 2800 mg bamlanivimab administered IV.
|
Phase 2: 7000 mg Bamlanivimab
n=101 Participants
Participants received 7000 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=112 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo
n=776 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=518 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=513 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
n=141 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
n=94 Participants
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
|
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
n=17 Participants
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
|
Total
n=2849 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 15.38 • n=156 Participants
|
43.5 years
STANDARD_DEVIATION 16.21 • n=101 Participants
|
44.4 years
STANDARD_DEVIATION 14.61 • n=107 Participants
|
45.7 years
STANDARD_DEVIATION 16.28 • n=101 Participants
|
43.9 years
STANDARD_DEVIATION 16.39 • n=112 Participants
|
53.4 years
STANDARD_DEVIATION 16.52 • n=776 Participants
|
54.3 years
STANDARD_DEVIATION 17.08 • n=518 Participants
|
54.5 years
STANDARD_DEVIATION 16.77 • n=513 Participants
|
53.6 years
STANDARD_DEVIATION 15.70 • n=141 Participants
|
52.7 years
STANDARD_DEVIATION 17.49 • n=213 Participants
|
9.9 years
STANDARD_DEVIATION 4.76 • n=94 Participants
|
26.19 years
STANDARD_DEVIATION 15.95 • n=17 Participants
|
51.9 years
STANDARD_DEVIATION 16.95 • n=2849 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=156 Participants
|
63 Participants
n=101 Participants
|
51 Participants
n=107 Participants
|
58 Participants
n=101 Participants
|
58 Participants
n=112 Participants
|
404 Participants
n=776 Participants
|
279 Participants
n=518 Participants
|
265 Participants
n=513 Participants
|
68 Participants
n=141 Participants
|
108 Participants
n=213 Participants
|
43 Participants
n=94 Participants
|
9 Participants
n=17 Participants
|
1491 Participants
n=2849 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=156 Participants
|
38 Participants
n=101 Participants
|
56 Participants
n=107 Participants
|
43 Participants
n=101 Participants
|
54 Participants
n=112 Participants
|
372 Participants
n=776 Participants
|
239 Participants
n=518 Participants
|
248 Participants
n=513 Participants
|
73 Participants
n=141 Participants
|
105 Participants
n=213 Participants
|
51 Participants
n=94 Participants
|
8 Participants
n=17 Participants
|
1358 Participants
n=2849 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=156 Participants
|
49 Participants
n=101 Participants
|
47 Participants
n=107 Participants
|
39 Participants
n=101 Participants
|
42 Participants
n=112 Participants
|
226 Participants
n=776 Participants
|
149 Participants
n=518 Participants
|
139 Participants
n=513 Participants
|
36 Participants
n=141 Participants
|
53 Participants
n=213 Participants
|
13 Participants
n=94 Participants
|
4 Participants
n=17 Participants
|
866 Participants
n=2849 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=156 Participants
|
52 Participants
n=101 Participants
|
60 Participants
n=107 Participants
|
62 Participants
n=101 Participants
|
70 Participants
n=112 Participants
|
548 Participants
n=776 Participants
|
368 Participants
n=518 Participants
|
373 Participants
n=513 Participants
|
104 Participants
n=141 Participants
|
160 Participants
n=213 Participants
|
80 Participants
n=94 Participants
|
13 Participants
n=17 Participants
|
1977 Participants
n=2849 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=156 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=776 Participants
|
1 Participants
n=518 Participants
|
1 Participants
n=513 Participants
|
1 Participants
n=141 Participants
|
0 Participants
n=213 Participants
|
1 Participants
n=94 Participants
|
0 Participants
n=17 Participants
|
6 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=156 Participants
|
1 Participants
n=101 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=776 Participants
|
2 Participants
n=518 Participants
|
3 Participants
n=513 Participants
|
2 Participants
n=141 Participants
|
3 Participants
n=213 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=17 Participants
|
15 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=156 Participants
|
1 Participants
n=101 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=101 Participants
|
2 Participants
n=112 Participants
|
33 Participants
n=776 Participants
|
16 Participants
n=518 Participants
|
18 Participants
n=513 Participants
|
6 Participants
n=141 Participants
|
6 Participants
n=213 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=17 Participants
|
98 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=156 Participants
|
0 Participants
n=101 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=112 Participants
|
4 Participants
n=776 Participants
|
0 Participants
n=518 Participants
|
1 Participants
n=513 Participants
|
0 Participants
n=141 Participants
|
0 Participants
n=213 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=17 Participants
|
6 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=156 Participants
|
7 Participants
n=101 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=101 Participants
|
4 Participants
n=112 Participants
|
61 Participants
n=776 Participants
|
44 Participants
n=518 Participants
|
41 Participants
n=513 Participants
|
16 Participants
n=141 Participants
|
28 Participants
n=213 Participants
|
67 Participants
n=94 Participants
|
12 Participants
n=17 Participants
|
302 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
White
|
133 Participants
n=156 Participants
|
90 Participants
n=101 Participants
|
90 Participants
n=107 Participants
|
89 Participants
n=101 Participants
|
105 Participants
n=112 Participants
|
667 Participants
n=776 Participants
|
449 Participants
n=518 Participants
|
445 Participants
n=513 Participants
|
116 Participants
n=141 Participants
|
175 Participants
n=213 Participants
|
22 Participants
n=94 Participants
|
5 Participants
n=17 Participants
|
2386 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=156 Participants
|
2 Participants
n=101 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=101 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=776 Participants
|
1 Participants
n=518 Participants
|
2 Participants
n=513 Participants
|
0 Participants
n=141 Participants
|
0 Participants
n=213 Participants
|
3 Participants
n=94 Participants
|
0 Participants
n=17 Participants
|
12 Participants
n=2849 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=156 Participants
|
0 Participants
n=101 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=101 Participants
|
1 Participants
n=112 Participants
|
7 Participants
n=776 Participants
|
6 Participants
n=518 Participants
|
3 Participants
n=513 Participants
|
1 Participants
n=141 Participants
|
1 Participants
n=213 Participants
|
2 Participants
n=94 Participants
|
0 Participants
n=17 Participants
|
30 Participants
n=2849 Participants
|
|
Region of Enrollment
United States
|
156 Participants
n=156 Participants
|
101 Participants
n=101 Participants
|
107 Participants
n=107 Participants
|
101 Participants
n=101 Participants
|
112 Participants
n=112 Participants
|
776 Participants
n=776 Participants
|
518 Participants
n=518 Participants
|
513 Participants
n=513 Participants
|
141 Participants
n=141 Participants
|
213 Participants
n=213 Participants
|
94 Participants
n=94 Participants
|
17 Participants
n=17 Participants
|
2849 Participants
n=2849 Participants
|
|
SARS-CoV-2 Viral Load
|
23.79 Cycle threshold (Ct)
STANDARD_DEVIATION 7.78 • n=152 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
23.80 Cycle threshold (Ct)
STANDARD_DEVIATION 6.55 • n=101 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
24.47 Cycle threshold (Ct)
STANDARD_DEVIATION 7.61 • n=107 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
23.42 Cycle threshold (Ct)
STANDARD_DEVIATION 6.78 • n=101 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
22.72 Cycle threshold (Ct)
STANDARD_DEVIATION 8.01 • n=109 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
24.26 Cycle threshold (Ct)
STANDARD_DEVIATION 8.194 • n=774 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
23.98 Cycle threshold (Ct)
STANDARD_DEVIATION 8.22 • n=508 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
24.15 Cycle threshold (Ct)
STANDARD_DEVIATION 7.28 • n=510 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
24.29 Cycle threshold (Ct)
STANDARD_DEVIATION 6.82 • n=141 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
25.62 Cycle threshold (Ct)
STANDARD_DEVIATION 7.33 • n=213 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
26.61 Cycle threshold (Ct)
STANDARD_DEVIATION 7.458 • n=86 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
28.79 Cycle threshold (Ct)
STANDARD_DEVIATION 7.053 • n=16 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
24.16 Cycle threshold (Ct)
STANDARD_DEVIATION 7.75 • n=2818 Participants • All participants who received at least one dose of study drug and had at least 1 post-baseline viral load measurement. Cycle threshold (Ct) denotes how many PCR cycles are required before the SARS-CoV-2 viral RNA reached a detectable level. Higher Ct values correspond to a lower viral load.
|
PRIMARY outcome
Timeframe: Baseline through Day 29Population: Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=517 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=518 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=776 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=511 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
|
7.0 percentage of participants
Interval 4.8 to 9.2
|
2.1 percentage of participants
Interval 0.9 to 3.4
|
6.8 percentage of participants
Interval 5.1 to 8.6
|
0.8 percentage of participants
Interval 0.0 to 1.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load \>=5.27 vs otherwise.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=141 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=213 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
|
34.8 percentage of participants
Interval 26.9 to 42.6
|
10.8 percentage of participants
Interval 6.6 to 15.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 11Population: Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=146 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=100 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=103 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=95 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=102 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
|
-3.80 unitless
Standard Error 0.141
|
-3.72 unitless
Standard Error 0.170
|
-4.08 unitless
Standard Error 0.168
|
-3.49 unitless
Standard Error 0.175
|
-4.37 unitless
Standard Error 0.169
|
—
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: Phase 2: All randomized participants who received at least one dose of study drug.
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=156 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=101 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=107 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=101 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=112 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
|
0.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.9 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 29 Post-dosePopulation: Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=95 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Bamlanivimab 700 mg: Weight Group: ≥40 kg
|
29.9 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 54.4
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Bamlanivimab 350 mg: Weight Group: >20 kg to <40 kg
|
23.7 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 45.6
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Bamlanivimab 175 mg: Weight Group: >12 kg to 20 kg
|
21.2 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 74.0
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Bamlanivimab 15 mg/kg: Weight Group: 1.5 kg to 12 kg
|
40.2 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 23.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29 Post-dosePopulation: Phase 2/3: All randomized participants who received a complete dose of Bamlanivimab and Etesevimab and had an evaluable PK sample on Day 29.
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=96 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Etesevimab 1400 mg: Weight Group: ≥40 kg
|
140 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 44.0
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Etesevimab 700 mg: Weight Group: >20 kg to <40 kg
|
129 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 36.7
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Etesevimab 350 mg: Weight Group: >12 kg to 20 kg
|
122 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 57.3
|
—
|
—
|
—
|
—
|
—
|
|
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Etesevimab 30 mg/kg: Weight Group: 1.5 kg to 12 kg
|
193 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 11.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 60 Post-dosePopulation: Phase 2/3: All randomized participants who received a complete dose of Bebtelovimab and had at least 1 post-dose PK sample.
AUC0-∞ for Bebtelovimab was reported.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=16 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
|
481 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 45.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 11Population: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=499 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=508 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=774 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=510 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=141 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Percentage of Participants Demonstrating Symptom Resolution
|
52.1 percentage of participants
Interval 47.7 to 56.5
|
61.2 percentage of participants
Interval 57.0 to 65.5
|
50.9 percentage of participants
Interval 47.4 to 54.4
|
61.8 percentage of participants
Interval 57.5 to 66.0
|
51.8 percentage of participants
Interval 43.5 to 60.0
|
63.8 percentage of participants
Interval 57.4 to 70.3
|
SECONDARY outcome
Timeframe: Day 11Population: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=499 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=508 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=774 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=510 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=141 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
|
40.9 percentage of participants
Interval 36.6 to 45.2
|
51.0 percentage of participants
Interval 46.6 to 55.3
|
40.1 percentage of participants
Interval 36.6 to 43.5
|
52.7 percentage of participants
Interval 48.4 to 57.1
|
38.3 percentage of participants
Interval 30.3 to 46.3
|
54.0 percentage of participants
Interval 47.3 to 60.7
|
SECONDARY outcome
Timeframe: Baseline through Day 85Population: Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.
COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=517 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=518 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=716 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=511 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=141 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=231 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
|
7.2 percentage of participants
Interval 4.9 to 9.4
|
2.5 percentage of participants
Interval 1.2 to 3.9
|
7.0 percentage of participants
Interval 5.2 to 8.7
|
1.2 percentage of participants
Interval 0.2 to 2.1
|
4.3 percentage of participants
Interval 0.9 to 7.6
|
0.9 percentage of participants
Interval 0.0 to 2.2
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: Phase 3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.
Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral and is unitless.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=403 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=455 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=614 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=399 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=122 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=194 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
|
-2.46 unitless
Standard Error 0.095
|
-3.66 unitless
Standard Error 0.090
|
-2.56 unitless
Standard Error 0.079
|
-3.65 unitless
Standard Error 0.098
|
-2.51 unitless
Standard Error 0.185
|
-3.50 unitless
Standard Error 0.147
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 3: All randomized participants (including censored) who received at least one dose of study drug and who had at least one post-baseline symptom measurement. Participants censored: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 121, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 88, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab= 226, 700 mg Bamlanivimab + 1400 mg Etesevimab= 128, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=44, 350 mg Bamlanivimab + 700 mg Etesevimab=43
Sustained symptom resolution was defined as 2 consecutive assessments with a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache; and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=499 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=508 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=774 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=510 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=141 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Time to Sustained Symptom Resolution
|
9.00 Days
Interval 8.0 to 10.0
|
8.00 Days
Interval 7.0 to 8.0
|
9.00 Days
Interval 9.0 to 10.0
|
8.00 Days
Interval 7.0 to 9.0
|
9.00 Days
Interval 8.0 to 13.0
|
6.00 Days
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 3: All randomized participants (Including censored) who received at least 1 dose of study drug and had at least 1 post-baseline viral load measurement. Censored participants: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab = 358, 2800 mg Bamlanivimab + 2800 mg Etesevimab = 325, Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab =530, 700 mg Bamlanivimab + 1400 mg Etesevimab= 326, Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab=95, 350 mg Bamlanivimab + 700 mg Etesevimab=114
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=499 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=508 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=774 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=510 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=141 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 Participants
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 3: Time to SARS-CoV-2 Viral Clearance
|
NA Days
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
|
NA Days
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
|
NA Days
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
|
NA Days
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
|
NA Days
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
|
NA Days
Interval 14.0 to
Median cannot be calculated due to insufficient number of events occurring within the timeframe.
|
SECONDARY outcome
Timeframe: Baseline, Day 11Population: Phase 2: All randomized participants who received at least one dose of study drug and had baseline and post-baseline viral load value. Participants enrolled with recent symptoms prior to randomization.
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=123 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=84 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=88 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=81 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=95 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
|
-4.03 unitless
Standard Error 0.155
|
-3.87 unitless
Standard Error 0.187
|
-4.20 unitless
Standard Error 0.184
|
-3.65 unitless
Standard Error 0.191
|
-4.46 unitless
Standard Error 0.178
|
—
|
SECONDARY outcome
Timeframe: Day 11Population: Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Resolution values
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise. Missing data were imputed using non-responder imputation (NRI) method.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=152 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=101 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=107 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=101 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=109 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants Demonstrating Symptom Resolution
|
36.8 percentage of participants
Interval 29.2 to 44.5
|
50.5 percentage of participants
Interval 40.7 to 60.2
|
40.2 percentage of participants
Interval 30.9 to 49.5
|
43.6 percentage of participants
Interval 33.9 to 53.2
|
45.9 percentage of participants
Interval 36.5 to 55.2
|
—
|
SECONDARY outcome
Timeframe: Day 11Population: Phase 2: All randomized participants who received at least one dose of study drug and had non-missing Symptom Improvement values
Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and changes in taste and smell. Each symptom will be scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=152 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=101 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=107 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=101 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=109 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants Demonstrating Symptom Improvement
|
43.4 percentage of participants
Interval 35.5 to 51.3
|
59.4 percentage of participants
Interval 49.8 to 69.0
|
44.9 percentage of participants
Interval 35.4 to 54.3
|
58.4 percentage of participants
Interval 48.8 to 68.0
|
53.2 percentage of participants
Interval 43.8 to 62.6
|
—
|
SECONDARY outcome
Timeframe: Day 29 Post-dosePopulation: Phase 2: All randomized participants who received a complete dose of Bamlanivimab (for Bamlanivimab only arms) or Bamlanivimab in the Presence of Etesevimab (for Bamlanivimab + Etesevimab) and had at least 1 post-dose PK sample.
(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=80 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=89 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=86 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=92 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
|
25.6 Microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 42.2
|
83.8 Microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 50.0
|
227 Microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 39.6
|
100 Microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 46.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 Post-dosePopulation: Phase 2: All randomized participants who received a complete dose of Etesevimab in the Presence of Bamlanivimab and had at least 1 post-dose PK sample.
PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=92 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
|
243 µg/mL
Geometric Coefficient of Variation 35.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 85Population: Phase 2: All participants who received at least one dose of study drug.
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=156 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=101 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=107 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=101 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=112 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
|
5.8 percentage of participants
Interval 2.1 to 9.4
|
1.0 percentage of participants
Interval 0.0 to 2.9
|
1.9 percentage of participants
Interval 0.0 to 4.4
|
2.0 percentage of participants
Interval 0.0 to 4.7
|
0.9 percentage of participants
Interval 0.0 to 2.6
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 2: All randomized participants (including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored: Part A: Placebo= 68, Phase 2: 700 mg Bamlanivimab=39, Phase 2: 2800 mg Bamlanivimab=40, Phase 2: 7000 mg Bamlanivimab=42 and Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab=45
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=152 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=101 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
n=107 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=101 Participants
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=109 Participants
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2: Time to SARS-CoV-2 Viral Clearance
|
24 Days
Interval 22.0 to
Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.
|
25.00 Days
Interval 21.0 to 27.0
|
23.00 Days
Interval 19.0 to 25.0
|
25.00 Days
Interval 22.0 to
Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.
|
21.00 Days
Interval 17.0 to
Some upper bound confidence intervals were not estimable due to insufficient events occurring within the timeframe.
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 2/3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization, COVID-Related Emergency Room (ER) Visit, or death from any cause data available.
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=94 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22]
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 7Population: Phase 2/3: All randomized participants who received at least one dose of study drug and had a baseline and day 7 viral load value.
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Viral load is reported as normalized viral load and is unitless.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=84 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
|
-4.37 unitless
Standard Deviation 2.740
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Phase 2/3: All randomized participants who received at least one dose of study drug and had a day 7 viral load value.
SARS-CoV-2 persistent high viral load (yes/no) is defined as RP normalized viral load \>5.27 vs otherwise. Percentage of response is calculated by n/Nx\*100% (n = number of participants in the specified category, Nx = number of participants with non-missing values)
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=92 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22]
|
10.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 2/3: All randomized participants (including censored) who received at least one dose of study drug and had non-missing Symptom Resolution values. Censored participants = 7.
Complete symptom resolution was defined as absence of all symptoms at a single timepoint.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=94 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3: Time to Complete Symptom Resolution [Arm 22]
|
5.00 days
Interval 4.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 2/3: All randomized participants (including censored) who received at least one dose of study drug and had non-missing Symptom Resolution values. Censored participants = 13.
Sustained complete symptom resolution is defined as the first of 2 consecutive days with complete symptom resolution.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=94 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22]
|
7.00 days
Interval 5.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through Day 29Population: Phase 2/3: All randomized participants (Including censored) who received at least one dose of study drug and had at least one post-baseline viral load measurement. Censored participants = 34.
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Outcome measures
| Measure |
Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=94 Participants
Participants received Placebo administered intravenously (IV).
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received Placebo administered intravenously (IV).
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
|---|---|---|---|---|---|---|
|
Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22]
|
11.00 days
Interval 8.0 to 13.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 2: Placebo
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Phase 2: 700 mg Bamlanivimab
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Phase 2: 2800 mg Bamlanivimab
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Phase 2: 7000 mg Bamlanivimab
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Serious events: 10 serious events
Other events: 72 other events
Deaths: 0 deaths
Phase 3: Placebo
Serious events: 8 serious events
Other events: 92 other events
Deaths: 15 deaths
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Serious events: 16 serious events
Other events: 61 other events
Deaths: 0 deaths
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2: Placebo
n=156 participants at risk
Participants received Placebo administered intravenously (IV).
|
Phase 2: 700 mg Bamlanivimab
n=101 participants at risk
Participants received 700 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab
n=107 participants at risk
Participants received 2800 mg bamlanivimab administered IV.
|
Phase 2: 7000 mg Bamlanivimab
n=101 participants at risk
Participants received 7000 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=112 participants at risk
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=518 participants at risk
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo
n=776 participants at risk
Participants received Placebo administered IV.
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=513 participants at risk
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
n=141 participants at risk
Participants received Placebo administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 participants at risk
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
n=94 participants at risk
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
|
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
n=17 participants at risk
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Macular oedema
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastritis
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Chest pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Sudden death
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Localised infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Syncope
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.36%
1/279 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.25%
1/404 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
Other adverse events
| Measure |
Phase 2: Placebo
n=156 participants at risk
Participants received Placebo administered intravenously (IV).
|
Phase 2: 700 mg Bamlanivimab
n=101 participants at risk
Participants received 700 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab
n=107 participants at risk
Participants received 2800 mg bamlanivimab administered IV.
|
Phase 2: 7000 mg Bamlanivimab
n=101 participants at risk
Participants received 7000 mg bamlanivimab administered IV.
|
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=112 participants at risk
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
n=518 participants at risk
Participants received 2800 mg bamlanivimab and 2800 mg etesevimab administered IV.
|
Phase 3: Placebo
n=776 participants at risk
Participants received Placebo administered IV.
|
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
n=513 participants at risk
Participants received 700 mg bamlanivimab and 1400 mg etesevimab administered IV.
|
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
n=141 participants at risk
Participants received Placebo administered IV.
|
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
n=213 participants at risk
Participants received 350 mg bamlanivimab and 700 mg etesevimab administered IV.
|
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
n=94 participants at risk
Pediatric participants received a Bamlanivimab + Etesevimab dose based upon weight (Bamlanivimab dose: weight Group: ≥40 kg = 700 mg dose, \>20 kg to \<40 kg = 350 mg dose, \>12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and Etesevimab dose: weight Group: ≥40 kg = 1400 mg dose, \>20 kg to \<40 kg = 700 mg dose, \>12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
|
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
n=17 participants at risk
Pediatric participants received Bebtelovimab dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, \>12 to ≤20 kg = 43.75 mg dose, \>20 to \<40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Swelling face
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Visual impairment
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Vitreous haemorrhage
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Retinopathy hypertensive
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Vision blurred
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.78%
4/513 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.94%
2/213 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Monocytopenia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Blepharitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Cataract
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Cataract nuclear
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Diplopia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Eye pain
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Eye paraesthesia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Photophobia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Retinal vein occlusion
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Eye disorders
Xanthopsia
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
5.9%
1/17 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
7/156 • Number of events 7 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
5.0%
5/101 • Number of events 5 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
3/776 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.8%
2/112 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/518 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Nausea
|
4.5%
7/156 • Number of events 8 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.0%
3/101 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.7%
4/107 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
4.0%
4/101 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.6%
4/112 • Number of events 5 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.97%
5/518 • Number of events 5 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.64%
5/776 • Number of events 5 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/513 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
4/156 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.8%
3/107 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Asthenia
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Chest discomfort
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Chest pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Chills
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.0%
3/101 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Extravasation
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.7%
3/112 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Fatigue
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Feeling abnormal
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Infusion site pain
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Infusion site rash
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Injection site extravasation
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Nodule
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Pyrexia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.9%
2/107 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/518 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Thirst
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
General disorders
Xerosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Immune system disorders
Hypersensitivity
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Candida infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Conjunctivitis
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Covid-19
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Ear infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/71 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/38 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/56 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/54 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/239 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.27%
1/372 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/248 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/73 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/105 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/8 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Eye infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Gangrene
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Localised infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Otitis media
|
1.3%
2/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pelvic inflammatory disease
|
1.2%
1/85 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pneumonia viral
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Sinusitis
|
1.9%
3/156 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Skin infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Tonsillitis
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/518 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.1%
3/141 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.94%
2/213 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.36%
1/279 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.25%
1/404 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.5%
1/68 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
1/51 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Amylase increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
6.4%
6/94 • Number of events 6 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
5.9%
1/17 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood glucose increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood pressure increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood urea increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood urine
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Epstein-barr virus antibody positive
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Heart rate irregular
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Lipase increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Liver function test increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
3/776 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/513 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.1%
2/94 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Occult blood positive
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Platelet count increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Transaminases increased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Weight decreased
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
5.3%
5/94 • Number of events 5 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
2/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.78%
4/513 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Burning sensation
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Dizziness
|
1.9%
3/156 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.0%
3/101 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.8%
3/107 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.0%
3/101 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.77%
4/518 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
3/776 • Number of events 4 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.78%
4/513 • Number of events 5 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Dysgeusia
|
1.3%
2/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Headache
|
1.3%
2/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.0%
3/101 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.9%
2/107 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Hypoaesthesia
|
1.3%
2/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Hyporeflexia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Incoherent
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Migraine
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/513 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Syncope
|
1.3%
2/156 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Nervous system disorders
Tremor
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
1/51 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
3/776 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Chromaturia
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/513 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/71 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/38 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/56 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/54 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/239 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/372 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/248 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.4%
1/73 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/105 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/8 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.25%
1/404 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.36%
1/279 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/51 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/108 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.8%
2/112 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/513 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
2/101 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.8%
3/107 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.8%
2/112 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/518 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/513 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.2%
6/518 • Number of events 6 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.77%
6/776 • Number of events 6 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.58%
3/513 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.4%
2/141 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.71%
1/141 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Social circumstances
Bereavement
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/85 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/63 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
2.0%
1/51 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/58 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/279 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/404 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/265 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/68 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/108 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/43 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/9 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Surgical and medical procedures
Thrombectomy
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.13%
1/776 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Dialysis hypotension
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/518 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Flushing
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Haematoma
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Hot flush
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Hypertension
|
0.64%
1/156 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.99%
1/101 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.0%
3/101 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.26%
2/776 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.4%
2/141 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.47%
1/213 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.39%
2/518 • Number of events 2 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.89%
1/112 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.19%
1/513 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.93%
1/107 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Infections and infestations
Influenza
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/94 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
17.6%
3/17 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
3.2%
3/94 • Number of events 3 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/156 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/107 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/101 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/112 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/518 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/776 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/513 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/141 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/213 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
1.1%
1/94 • Number of events 1 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
0.00%
0/17 • Baseline Up to 85 Days
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly. Phase2/3 Pediatric Arms did not collect adverse events by dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60